Resonate family of CRT-D's
FDA premarket approval P960040/S466 · decided 2021-10-07
Approval details
- PMA number
- P960040
- Supplement
- S466
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Resonate family of CRT-D's
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-07-07
- Decision date
- 2021-10-07
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for labeling updates to reflect findings of the Strategic Management to Improve CRT (SMART) Multi-Site Pacing (MSP) clinical study.
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