|
Device | S-ICD GEN 2 A209, S-ICD EMBLEM 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 | S187 |
Date Received | 07/10/2023 |
Decision Date | 07/20/2023 |
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 Change the high voltage capacitor rivet slot width dimensional inspection method. |