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 | CARPENTIER-EDWARDS BIOPROSTHESIS |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P870056 |
Supplement Number | S011 |
Date Received | 03/26/1999 |
Decision Date | 04/13/1999 |
Withdrawal Date
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01/28/2022 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly. |
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