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. |
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Device | EDWARDS SAPIEN TRANSCATHETER HEART VALVE |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P100041 |
Supplement Number | S012 |
Date Received | 06/13/2012 |
Decision Date | 07/11/2012 |
Withdrawal Date
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03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-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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