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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
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP100041
Supplement NumberS012
Date Received06/13/2012
Decision Date07/11/2012
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
An increase in the number of hepa filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door.
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