RELIANCE 4-FRONT
FDA premarket approval P910073/S157 · decided 2020-07-07
Approval details
- PMA number
- P910073
- Supplement
- S157
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- RELIANCE 4-FRONT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-04-16
- Decision date
- 2020-07-07
- Days to decision
- 82 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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