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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP100041
Supplement NumberS066
Date Received02/18/2015
Decision Date03/20/2015
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Add a chamber to the ethylene oxide sterilization process at the sterigenics facility (salt lake city, utah).
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