|
Device | EMBLEM S-ICD VI Electrode (Lead) |
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 | S192 |
Date Received | 11/08/2023 |
Decision Date | 12/08/2023 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval of the revised protocol for the EMBLEM S-ICD Electrode Model 3501 PAS |