|
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 | S174 |
Date Received | 09/30/2022 |
Decision Date | 12/12/2022 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the product labeling for the Accolade family of pacemakers and cardiac resynchronization therapy pacemakers to provide additional clarity. |