|
Device | A209 SICD Gen 2, A219 SICD MRI |
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 | S194 |
Date Received | 03/25/2024 |
Decision Date | 04/05/2024 |
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 a new Macro laser welder (LW) system and updates to two existing LW systems to perform the laser weld process |