|
Device | Resonate family of CRT-D's |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S466 |
Date Received | 07/07/2021 |
Decision Date | 10/07/2021 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03257436
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling updates to reflect findings of the Strategic Management to Improve CRT (SMART) Multi-Site Pacing (MSP) clinical study. |