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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEDWARDS SAPIEN TRANSCATHETER HEART VALVE
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
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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