- Device
- RESONATE™ HF, RESONATE™ EL, MOMENTUM™ EL, VIGILIANT™ EL, PERCIVA™ HF, PERCIVA™
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S476
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-08-26
- Decision code
- APPR
- Date received
- 2022-03-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the MANAGE-HF Post Approval Study (PAS) to be transitioned to the HeartLogic PAS Analysis Plan.