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Device | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC CORPORATION 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P110042 |
Supplement Number | S130 |
Date Received | 10/21/2019 |
Decision Date | 10/29/2019 |
Product Codes |
LWS NVY |
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 Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method. |