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Device | Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830060 |
Supplement Number | S087 |
Date Received | 09/30/2021 |
Decision Date | 10/04/2021 |
Product Code |
LWS |
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 Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier. |