RESONATE HF, RESONATE, RESONATE X4, MOMENTUM, MOMENTUM X4, VIGILIANT, VIGILIANT X4
FDA premarket approval P010012/S552 · decided 2022-08-26
Approval details
- PMA number
- P010012
- Supplement
- S552
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- RESONATE HF, RESONATE, RESONATE X4, MOMENTUM, MOMENTUM X4, VIGILIANT, VIGILIANT X4
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2022-03-23
- Decision date
- 2022-08-26
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the MANAGE-HF Post Approval Study (PAS) to be transitioned to the HeartLogic PAS Analysis Plan.
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