MANAGE HF Study
FDA premarket approval P960040/S426 · decided 2018-08-21
Approval details
- PMA number
- P960040
- Supplement
- S426
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MANAGE HF Study
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-06-22
- Decision date
- 2018-08-21
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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