RELIANCE 4-SITE LEAD FAMILY
FDA premarket approval P910073/S132 · decided 2016-02-22
Approval details
- PMA number
- P910073
- Supplement
- S132
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIANCE 4-SITE LEAD FAMILY
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-08-07
- Decision date
- 2016-02-22
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for ACUITYX4 leads and accessories.
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