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 |
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PMA Number | P100041 |
Supplement Number | S032 |
Date Received | 06/06/2013 |
Decision Date | 07/03/2013 |
Product Code |
NPT
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Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
IMPLEMENTATION OF A POSITIONING FIXTURE AS AN ALTERNATIVE MANUFACTURING AID USED WHILE PLACING TEMPORARY STITCHES ON TISSUE LEAFLETS. |
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