Breast Pump

Product Comparison: Ameda Breast Pumps vs. Medela Breast Pumps – Which is the Better Buy?

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Overview

Thinking of getting a breast pump from Ameda or Medela but unsure what model to pick?

Both brands have different kinds of pumps: single and double electric breast pumps, portable pumps, heavy-duty hospital-grade pumps, hands-free pumps, and manual pumps.

So, which one should you choose?

In our product comparison of Ameda vs. Medela Breast Pumps, you’ll learn more about the similarities and differences between these breast pumps.

You’ll also find breast pump reviews from moms who tried these products. Which models did these moms like best? Which models can you get as a free breast pump through insurance?

Continue reading below to learn more.

General Product Comparison Ameda Vs. Medela Breast Pumps

Main Similarities

  • Both brands have a wide range of breast pumps that cater to every mom’s different needs: battery-operated portable pumps, electric pumps with AC adapter and portability options (built-in rechargeable battery pack), manual pumps, and heavy-duty hospital-grade pumps.
  • Both brands offer a three-year limited warranty on their heavy-duty hospital-grade pumps.
  • Both brands promise to provide moms with a great pumping experience with their wide range of pumps.
  • Their bottles and accessories are made from BPA-free materials (bisphenol-A; toxic chemicals used to manufacture plastics).

What Makes Ameda Better

  • Ameda offers a two-year warranty on most of the pumps, while Medela only offers a one-year warranty.
  • Ameda pumps have more adjustable or custom settings than Medela pumps.
  • All Ameda pumps have a closed system, while most Medela pumps have a less hygienic open system.
  • It doesn’t have product recalls for performance issues.

What Makes Medela Better

  • Medela pumps have a letdown mode to promote better milk flow.
  • Medela pumps have pre-programmed settings that new moms might find more user-friendly than a pump with more adjustable suction settings.
  • Medela spare parts such as chargers, breast shields, valves, bottles, tubings, and many others are easy to find, even in retail outlets such as Target and Walmart.

In this product comparison of Ameda vs. Medela Breast Pumps, we compare the two brands based on their similar models:

Ameda Purely Yours Vs. Medela Pump In Style Advanced

Ameda Purely YoursWALMART BUTTONAMAZON BUTTON

Medela Pump in Style Advanced

Similarities

  • These two are both double electric breast pumps that can also be used as a single pump.
  • They can be used both plugged in and with batteries.
  • They both use dials and buttons.
  • They don’t have an LCD display.
  • You might get any of these two breast pumps free through insurance, depending on your coverage.
  • Both can be used hands-free if you wear a pumping bra.
  • Both pumps are easy to use and can be a good option for new moms.
  • Both have product recalls: Incorrect AC power adapters for the Ameda (Lot 7E058 and Lot 7E308) in 2017, and pump performance issues for the Medela (manufacture dates: February 10 to March 3, 2010) in 2010. Both brands replaced the affected products. (1)(2)

What Makes The Ameda Purely Yours Better

  • The Ameda pump has a hygienic closed system, while the Medela pump has an open system.
  • The Ameda Purely Yours Ultra costs less than the Medela Pump in Style Advanced.
  • The Purely Yours is lighter (2.30 lbs) than the Pump in Style Advanced (7.0 lbs).
  • You’ll only need six AA batteries with the Purely Yours, but the Pump in Style Advanced requires eight.
  • The Ameda pump has two sets of bigger-sized flanges with extra two breast-reducing inserts.
  • The Ameda pump has a bigger cooler that can fit six bottles, while the Medela’s can only fit four.
  • The Ameda has a two-year warranty, but the Medela only has a one-year warranty.

What Makes The Medela (PISA) Pump In Style Advanced Better

  • The Ameda pump isn’t hospital-grade, but the Medela one is suited for heavy-duty pumping.
  • The Purely Yours Ultra can only go up to 200 mmHg, but the Pump in Style can reach 250 mmHg.
  • The Medela has a two-phase expression technology with the massage button to promote more milk expression, but the Ameda only uses a single-phase system.
  • The Medela is quieter.
  • The Medela tote is larger and can fit other items aside from the entire milk collection system.

What Customers Say: Ameda Purely Yours

Positive Reviews

My favorite part about this pump is that it’s a closed system, so you can’t get any milk into the tubes or machine. The valves do wear out, but that’s why they’re designed to be easily replaced – it’s important to create a vacuum for it to work.” – Reviewer on Amazon.

Negative Reviews

I needed a pump that I could use for pumping at work for a year. This was cheaper than renting for that long. When I first started using it five months ago, it worked well. It still works ok, but the pumping mechanism in the base seems to have loosened a little, and now part of it pushes out of the unit. This seems to have affected the suction a little, and it makes more noise now. It still does its job, but it’s certainly not what it started out as. I hope it lasts for the year.” – Reviewer on Amazon.

What Customers Say: Medela Pump In Style Advanced

Positive Reviews

It works great. Super easy to use.” – Reviewer on Walmart.

Negative Reviews

I’ve been lightly using my Medela since May. But even with letting the pump run and clear the tubing, it has left black mold in the tubes. So, I’m now having to replace multiple parts and dump everything I’ve pumped in three days.” – Reviewer on Walmart.

Ameda Finesse Vs. Medela Freestyle Flex

Ameda Finesse

Medela Freestyle FlexMedela Freestyle

Similarities

  • Both are portable pumps.
  • Both are hospital-grade pumps.
  • Both can be used as single and double electric pumps.
  • Both can go up to 250 mmHg.
  • Both have a closed system pump.
  • Both are quiet pumps.
  • Both can be good pumps for working moms who need to express milk in the office or other work areas.

What Makes The Ameda Finesse Better

  • The Ameda Finesse is cheaper than the Medela Freestyle Flex.
  • The Ameda weighs lighter (1.1 lbs) than the Medela (5.09 lbs).
  • The Ameda has more customization options, with 32 different adjustable suction and speed settings.
  • The Ameda has a two-year warranty, while the Medela only has a one-year warranty.

What Makes The Medela Freestyle Flex Better

  • The Medela has a built-in battery pack that can last for two hours, while the Ameda uses six AA batteries, sold separately.
  • The Medela uses a two-phase expression technology to promote letdown.
  • The Medela is a smart pump with an LCD touchscreen and can be linked to a phone app.

What Customers Say: Ameda Finesse

Positive Reviews

I liked this pump so much better than the Medela. I gave it 4 out of 5 stars because you cannot pump just one boob. I was able to empty my full supply in 30-minute sessions. It’s compatible with the Medela bottles. Even though you can’t find it in a grocery store, you can buy everything for cheap on Amazon.” – Reviewer on Amazon.

Negative Reviews

I’ve been using it for about two months now. The suction randomly stops working, and sometimes it won’t turn on. There isn’t really a gradual suction to it either. It’s all or nothing, which can be painful at times. Otherwise, it works fine. Parts aren’t super easy to clean.” – Reviewer on Walmart.

What Customers Say: Medela Freestyle Flex

Positive Reviews

This pump is well worth every penny, and I only regret not buying it sooner! This pump has been life-changing for me! My supply has gone from pumping 5-7oz in the morning to 10-12oz consistently! The flanges are so comfortable, and with so many different settings, it makes pumping almost feel like a massage in comparison to the awful Ameda pump I had before.” – Reviewer on Walmart.

Negative Reviews

I bought this three months ago, and unfortunately, it hasn’t been working for me. I use this pump as my go-to pump now, and it was working great, but it stopped working. It’s fully charged, but I can’t get it to turn on, and it’s really difficult for me since I rely on it very much. I haven’t been able to get in contact with Medela support.” – Reviewer on Walmart.

Ameda Mya Joy Vs. Medela Pump in Style with MaxFlow Technology

Ameda Mya JoyAmeda Mya Joy

Medela Pump in Style with MaxFlow Technologymedlela breast pump in style

Similarities

  • Both are portable and can also be used plugged in with an AC adapter.
  • Both can be used as single and double breast pumps.
  • Both pumps are hospital-grade.
  • Both are closed-system pumps.
  • Both use buttons for the settings.
  • Both come with a tote bag.

Is Ameda Mya Joy A Good Pump?

  • The Ameda Mya Joy is cheaper than the Medela Pump in Style with MaxFlow Technology.
  • The Ameda is lighter (0.5 lbs) than the Medela (1.18 lbs).
  • The Ameda only uses four AA batteries, while the Medela needs eight AA batteries.
  • The Ameda has an LCD display, while the Medela doesn’t have any.
  • The Ameda has two-phase adjustable suction modes: stimulation (six levels) and expression mode (12 levels).
  • The Ameda has a warranty of two years, while the Medela only has a one-year warranty.
  • The Ameda is small and can be clipped right onto your waistband or inside a purse pocket.

What Makes The Medela Pump in Style With MaxFlow Technology Better

  • The Medela can go up to 270 mmHg, while the Ameda can only do up to 250 mmHg.
  • The Medela uses more batteries and may last longer than the Ameda.
  • The Medela has pre-programmed speed and vacuum settings.

What Customers Say: Ameda Mya Joy

Positive Reviews

Love this pump — it’s the only one I use (and I got multiple). Powerful, quiet, lightweight. Super easy to use — I put it together and figured out how to use it in two minutes on about two hours of sleep. Works well with a hands-free pumping bra (or nursing bra converted to hands-free pumping bra) — stays put, including during breast massage. Highly recommend it!” – Reviewer on Amazon.

Negative Reviews

While in the hospital, I used the Ameda pump they provided, and it worked great. I bought this one because it is the same brand and I could use all the parts I came home from the hospital with. Unfortunately, the suction on this is so terrible I cannot even get an ounce pumped combined after 40 minutes! However, I was easily getting better between 2.5 and 3 ounces combined in less than 30 minutes using the Ameda pump at the hospital.” – Reviewer on Amazon.

What Customers Say: Medela Pump in Style With MaxFlow Technology

Positive Reviews

Much better upgrade compared to the old Medela pump. This one is more compact, quieter, and easy to use. I love the vibration it has when pumping to help mimic the baby’s latch/suction. The vibration also helps get the milk out! I just wish it wouldn’t automatically use the letdown function every minute.” – Reviewer on Aeroflow Breast Pumps.

Negative Reviews

Do not waste your time on this one. It’s funny it says it’s comparable to a hospital pump, but it’s not even close. I’m so disappointed. Do your research and find a different type of pump. Your nipples will thank you later, along with your milk supply.” – Reviewer on Aeroflow Breast Pumps.

Ameda Mya Portable Vs. Medela Swing Single Electric Breast Pump

Medela Swing Single Electric Breast PumpWALMART BUTTON

Ameda Mya PortableAmeda Mya Portable

Similarities

  • The two pumps have the same price
  • Both are portable.
  • Both have batteries that can last for up to two hours.
  • Both have buttons for the controls.

Which Breast Pump Is Better Ameda Mya Or Medela?

Ameda Mya Highlights

  • The Ameda Mya Portable weighs less (0.5 lbs) than the Medela Swing Single Electric Breast Pump (2.5 lbs).
  • The Ameda can be used both as a double and single pump, but the Medela is only a single pump.
  • The Ameda has a stronger pump (up to 280 mmHg) than the Medela pump (up to 250 mmHg).
  • The Ameda has two-phase adjustable suction modes: with 10 levels of expression mode and five levels of massage/stimulation mode.
  • The Ameda is a closed system pump, while the Medela is an open-system pump.
  • The Ameda has an LCD display, while the Medela has none.
  • The Ameda has a two-year warranty, while the Medela only has a year warranty.
  • The Ameda fits in a purse pocket and clips right onto your waistband.

Medela Swing Highlights

  • The Medela comes with a drawstring bag, but the Ameda doesn’t have any.

What Customers Say: Ameda Mya Portable

Positive Reviews

I have had two other pumps that I felt like I was tied down. With this one, I stay on the go. I actually bought cups that go in my bra to use with it. I get more when I use the cups that came with it, but I have a pumping bra that holds them. I use the others when I am working or out and about. It’s great. I can pump four times for 30 minutes each session, and it will still be charged. I even pump while I am riding horseback using this one.” – Reviewer on Aeroflow Breast Pumps.

Negative Reviews

Please, ladies, don’t waste your time with this pump! I’m on my second replacement of this pump, and it just broke again! I have been breastfeeding for three months and have been using it 3-4 times a day.” – Reviewer on Aeroflow Breast Pumps.

What Customers Say: Medela Swing Single Electric Breast Pump

Positive Reviews

This pump is perfect for that. It’s plenty powerful – the variable suction strength more than exceeds what I need to pump as efficiently as possible. I usually use it plugged into an outlet, but I’ve had to run it on the batteries probably a dozen times so far, and I’m still on the original set of batteries. It’s compact and comes with a carry bag, so everything stays together in my day bag when I’m out of the house.” – Reviewer on Amazon.

Negative Reviews

I can not WAIT to throw this thing in the trash. It is not nearly as powerful as the Medela In Style. I have to crank it all the way up every time and still have to work hard with hand manipulation to get anything worthwhile out. With all the same factors considered, I get about half the volume in a pumping session as I do with my In Style. This pump also has the most irritating vibration to it. With every pump, it vibrates like a slow torturous tickle.” – Reviewer on Amazon.

Ameda One-Hand Breast Pump Vs. Medela Harmony Manual Breast Pump

Ameda One-Hand Breast Pumpameda one hand

Medela Harmony Manual Breast Pump

Similarities

  • They’re both manual pumps.
  • Both don’t require batteries.
  • Moms usually pick them for portability.
  • Both are single pumps with a closed system.

What Makes The Ameda One-Hand Breast Pump Better

  • The Ameda lets you pump directly into any standard baby bottle or milk storage bag.
  • The Ameda is a mechanical manual pump that you squeeze sideways with one hand.
  • The Ameda is lighter (0.28 lbs) than the Medela (1.1 lbs).

What Makes The Medela Harmony Manual Breast Pump Better

  • The Medela Harmony has a lever that might be easier to use for pumping.
  • The Medela is cheaper than the Ameda.

What Customers Say: Ameda One-Hand Breast Pump

Positive Reviews

Easy to assemble. It takes milk out great. Perfect to put in the diaper bag when you don’t want to breastfeed in public, also to relieve engorgement. It works great and is very strong. I have the double electric in this brand and love them both. The hospital recommends it since I have twins.” – Reviewer on Amazon.

Negative Reviews

This breast pump wasn’t for me. I bought it because mechanically, it looked like it would be easier to use, but that wasn’t the case. I hated the sideways squeezing and could never get enough suction to actually pump any breast milk. So I bought a Medela hand pump and never looked back.” – Reviewer on Amazon.

What Customers Say: Medela Harmony Manual Breast Pump

Positive Reviews

I use this to quickly and easily express at night when we’ve given the baby a bottle of expressed milk – it’s less of a faff than using my electric pump. It doesn’t draw out as much milk, but I love the convenience of a manual pump for nighttime expression. It’s much less disruptive and easier to clean and assemble.” – Reviewer on Amazon.

Negative Reviews

Just after a week of purchase, suction has weakened very much. So it’s not at all value for money at this price as just after using it for 15 days we will have to buy another pump. So instead of wasting money on this, buy some other company product at a lower price. Because at this cost you can easily buy 2-3 pumps from some other company at a cheaper price.” – Reviewer on Amazon.

Which Breast Pumps Are Hospital Grade? Ameda Platinum Vs. Medela Symphony

Medela SymphonyMedela SymphonyEBAY BUTTONAMAZON BUTTONWALMART BUTTON

Ameda PlatinumAmeda PlatinumWALMART BUTTONAMAZON BUTTON

Similarities

  • They’re both hospital-grade pumps designed for heavy-duty use by multiple users.
  • They’re both able to reach vacuum strength up to 250 mmHg.
  • Both can be attached to stands to be wheeled around.
  • Both come with a three-year limited warranty.
  • Both are quiet and designed for a hospital setting.
  • Both have a closed system.
  • Both these pumps can be used for single or double pumping.

What Makes The Ameda Platinum Better

  • The Ameda has eight adjustable suction settings and four adjustable cycle speeds that simulate your baby’s nursing patterns for a faster pumping time.
  • The Ameda offers a Cool n Carry Tote and cooler bag that can keep your breastmilk cool for up to 10 hours, even without a fridge.
  • The Ameda comes with a hard case for protection.
  • The Ameda has an easy-to-clean flat-front control panel.
  • The Ameda comes with a laminated quick start guide with a metal ring for optional attachment to the pump.
  • The Ameda has soft-touch, push-button controls for vacuum and cycle settings.
  • The Ameda has LCD panels to show the suction levels and settings.
  • The Ameda didn’t have product recalls. (Pumps with lot # 67099S of the Symphony were recalled in 2010 for compromised product sterility due to possible pinholes in the rigid tray of the package. Medela replaced the affected products.) (3)

What Makes the Medela Symphony Better

  • The Medela is cheaper than the Ameda.
  • The Medela is lighter (7.05 lbs) than the Ameda (9.7 lbs).
  • The Medela Symphony has a one-knob control.
  • The Medela uses two-phase expression technology with a one-touch letdown button.

What Customers Say: Ameda Platinum

Positive Reviews

I’m renting it through the hospital, and it drains my breasts. My baby often falls asleep on the breast or refuses to breastfeed, so I have to pump to keep the supply up. This pump does a great job emptying my breasts. It is essential in building a supply. My personal pumps at home – Medela PISA, Spectra S2, and Ameda Purely Yours don’t even compare – the output is much less. I’ll use those at work later, but for now, while at home and during the first vital weeks when I need to build the supply, this pump is the best!” – Reviewer on Amazon.

Negative Reviews

Great suction power but archaic in design. Milk can spray up into the membrane, and then you lose suction on your entire pump. Why would a $2000 machine be made so faulty!” – Reviewer on Amazon.

What Customers Say: Medela Symphony

Positive Reviews

Hospital grade suction power is true to its word. I noticed a significant increase in breast milk output even on the first pump. As an exclusive pumper, this product was a life changer and a must-have. Easy to use and clean. Definitely worth every penny.” – Reviewer on Amazon.

Negative Reviews

Not worth the price. Not at all. I have owned multiple breast pumps & this one cost more. It broke more often & was the least comfortable. I would tolerate all that if I got more milk, but it did not improve my production either. Don’t make the same expensive mistake I did!” – Reviewer on Amazon.

FAQs About Breast Pumps

Why Would I Need A Breast Pump?

New moms might be unsure whether they need a pump, but one can be handy for keeping an emergency milk supply in your fridge. A breast pump can also help with engorgement and clogged ducts.

What Are The Benefits Of Breastfeeding And Pumping?

  • It helps your uterus contract to return to its original position.
  • It helps minimize postpartum bleeding.
  • It provides your baby with colostrum (nutrient-rich milky fluid produced by your body immediately after giving birth).
  • It provides your baby with an unlimited supply of free, fresh, and chemical-free milk.

Do I Need A Lactation Consultant?

It’s not a requirement for breastfeeding moms, but having a lactation consultant certified by the International Board of Certified Lactation Consultants can help you handle all your breastfeeding concerns.

They can help you learn how to breastfeed and pump. Plus, they can also help you with concerns such as:

  • Latching positions
  • Latching techniques
  • Nursing patterns
  • Nursing through sickness (yours or your baby’s)
  • Nursing babies with special needs
  • Weaning

Which Breast Pump Supplier Is Best?

  • You can get a free manual or electric breast pump from insurance through medical supply companies like Aeroflow and Edgepark. Aeroflow may be a better choice because you can easily check for the prices and descriptions of each breast pump.
  • You can also choose to buy from a retail outlet and simply have the item reimbursed by your insurance company. But check with your insurance company if they pay for pumps bought from a retail outlet or only with accredited medical supply companies.
  • You can also rent a hospital-grade pump. But most insurance companies don’t cover rental breast pumps.

What’s The Best Breast Pump: Manual or Electric?

  • Manual pumps are much cheaper than electric pumps, but their capabilities are limited. Most moms suggest that you only get manual pumps if you only pump occasionally.
  • Electric breast pumps can help you express and collect more milk more quickly.
  • They’re expensive but you can get electric pumps for free through insurance. Many models are available for free, without any additional cashouts.

Which One Should I Choose: Single Or Double Pump?

  • Single breast pumps are less expensive but can only be used for one breast at a time. You can choose these pumps if you only need to pump occasionally.
  • Double breast pumps are more expensive but offer more versatility than single pumps.

What Batteries Do Breast Pumps Use?

Different types of breast pumps use different types of batteries. Some have built-in rechargeable battery packs, while others use AA batteries.

When Should I Change My Pump’s Valves?

When you notice that the suction strength isn’t as strong as when the pump was new, it’s time to change the valves.

Also, check the other pump spare parts, especially the tubings, for signs of molds or other issues so you can also replace them.

Do I Have To Wash My Pump After Every Use?

Yes. It is important to keep the breast pump clean after every use because mold, bacteria, and viruses can grow on the dirty pump parts.

Although breast milk is clean when fresh, it can make an excellent breeding ground for these microbes to live in your breast pump if it becomes stale in the pump parts.

How Do I Clean My Breast Pump?

No matter what breast pump you have, only use clean water and gentle baby-friendly soap to clean all the parts.

Before cleaning, read the instructions carefully. These will indicate how you can clean your pump and which parts are dishwasher safe.

If possible, just handwash the pump parts and dry them on the counter, away from high-traffic areas in your kitchen or the baby’s room.

What’s The Strongest Breast Pump?

The Baby Buddha Double Electric Breast Pump can reach a vacuum strength of up to 320 mmHg.

Many hospital-grade pumps go as high as 270 to 300 mmHg.

Note that “hospital-grade” is a marketing term used by brands to describe their personal-use pumps, but these are not actually certified by the FDA (Food and Drug Administration) as real hospital-grade pumps.

Also, a stronger suction isn’t a guarantee that you’ll get more milk from a pump.

What’s the Best Breast Pump for Twins?

You’ll need a powerful, durable breast pump if you have twins.

Stronger pumps like the real hospital-grade FDA-approved pumps such as the Medela Symphony or the Ameda Platinum can handle your heavy-duty pumping requirements.

The Spectra Synergy Gold is another good option. It can pump up to 270 mmHg for each breast, unlike other personal-use breast pumps that usually split the vacuum strength between the two breasts when used for double pumping.

Which Ameda Pump Is Best?

The Ameda Platinum may be the brand’s best pump. It has more features and has the strongest suction power.

What Useful Breast Pump Accessories Should I Buy?

  • Hands-free pumping bra
  • Hands-free milk collection cups
  • Milk storage bags
  • Soft, small brushes for cleaning
  • Drying rack
  • Microwave sanitation bag for your pump parts
  • Spare parts such as valves, membranes, tubings, and caps
  • Breast shields and flanges of different sizes
  • Cooler bag for storing your pumped milk
  • Breast pads
  • Car charger
  • Extra rechargeable batteries
  • Tote bag or backup that can fit the pump and milk collection kit

How Often Should I Pump?

The amount of breast milk you produce actually follows the law of supply and demand.

A two-month-old baby usually needs to feed every two hours, while a three-month-old baby usually feeds every three hours. This is because the younger baby usually needs less milk per feeding session.

So, it’s best to fit your pumping schedule to mimic your baby’s feeding schedule. But try to add at least one extra session, if possible, to help establish your milk supply and let you have some extra stored milk in your fridge.

Tips For Successful Breast Pumping

  • Get everything ready before you start pumping. Prepare extra bottles or milk collection bags.
  • Make sure to clean your pump, bottles, and milk bags before you use them.
  • If you can, invest in a pumping bra for hands-free pumping.
  • Relax and massage your breasts gently if your pump doesn’t have a massage and letdown mode.
  • Experiment with your breast pump’s different levels and settings. Find the best one that lets you express more milk but doesn’t hurt your nipples.
  • Build up your milk supply with regular pumping.
  • Try to pump at around the same time daily. Sticking to a schedule can help you establish your milk supply even when you’re busy.

Summary & Recommendation

Based on our product comparison above, it’s clear that both brands have their own advantages and disadvantages over the other.

In general, you should choose Ameda if:

  • You want a safe brand that doesn’t have product recalls relating to safety and pump performance issues.
  • You want more choices with hygienic closed-system pumps.
  • You want a pump with a two-year warranty.
  • You want a pump with more adjustable suction and speed settings.
  • You don’t mind not having a letdown button on your pump.

You should choose Medela if:

  • You want a pump with a letdown mode for better milk flow.
  • You want an easy-to-use pump with pre-programmed settings.
  • You want a pump with spare parts that are easy to find.
  • You don’t mind having only a one-year warranty.
  • You don’t mind that the brand has had some product recalls on certain models in the past.

 

 

 

 

REFERENCES:

(1) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=158977

(2) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96744

(3) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93790

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