|
Device | SICD Gen 2 A209, SICD MRI A219 |
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 | S171 |
Date Received | 06/29/2022 |
Decision Date | 07/13/2022 |
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 Addition of Ansell nitrile gloves as an alternative glove for use during cardiac rhythm management (CRM) pulse generator manufacturing at the St. Paul site. |