RESONATE HF, RESONATE EL, MOMENTUM EL, VIGILIANT EL, PERCIVA HF, PERCIVA
FDA premarket approval P960040/S476 · decided 2022-08-26
Approval details
- PMA number
- P960040
- Supplement
- S476
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- RESONATE HF, RESONATE EL, MOMENTUM EL, VIGILIANT EL, PERCIVA HF, PERCIVA
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-03-23
- Decision date
- 2022-08-26
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval of the MANAGE-HF Post Approval Study (PAS) to be transitioned to the HeartLogic PAS Analysis Plan.
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