RELIANCE 4-FRONT
FDA premarket approval P910073/S179 · decided 2024-12-03
Approval details
- PMA number
- P910073
- Supplement
- S179
- 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
- 2024-09-06
- Decision date
- 2024-12-03
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval to replace the polyurethane raw material used to manufacture lead body tubing on RELIANCE 4-FRONT leads
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