Reliance 4- Front Lead Family and Suture Sleeve Accessory
FDA premarket approval P910073/S145 · decided 2018-05-04
Approval details
- PMA number
- P910073
- Supplement
- S145
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Reliance 4- Front Lead Family and Suture Sleeve Accessory
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-12-12
- Decision date
- 2018-05-04
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the RELIANCE 4-FRONT lead family and suture sleeve accessory (Model 6403).
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