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 | PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm) |
Generic Name | Mitral valve repair devices |
Applicant | Edwards LifeSciences LLC One Edwards Way Irvine, CA 92614 |
PMA Number | P220003 |
Supplement Number | S001 |
Date Received | 10/12/2022 |
Decision Date | 10/19/2022 |
Product Code |
NKM |
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 Change in yarn extruder and an additional bias cloth manufacturing step. |
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