RELIANCE 4-FRONT
FDA premarket approval P910073/S165 · decided 2021-12-23
Approval details
- PMA number
- P910073
- Supplement
- S165
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIANCE 4-FRONT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-09-27
- Decision date
- 2021-12-23
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for minor design changes to the lead terminal component and minor labeling updates
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