|
Device | WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (FLX) |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S045 |
Date Received | 07/30/2021 |
Decision Date | 08/25/2021 |
Product Code |
NGV |
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 Add an alternate sterilization site with additional PCDs to sterilize the WATCHMAN FLX LAAC device. |