RELIANCE 4-SITE
FDA premarket approval P910073/S092 · decided 2011-02-11
Approval details
- PMA number
- P910073
- Supplement
- S092
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIANCE 4-SITE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-12-17
- Decision date
- 2011-02-11
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A DECREASE IN THE LENGTH OF THE POLYURETHANE TUBING PRESENT AT THE PROXIMAL END OF THE LEAD AND A LABELING NOTE REGARDING IMPLANTATION TECHNIQUE.
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