RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD
FDA premarket approval P910073/S116 · decided 2013-05-07
Approval details
- PMA number
- P910073
- Supplement
- S116
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-03-19
- Decision date
- 2013-05-07
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR AN ALTERNATE PRIMER MATERIAL FOR THE FLEXTEND AND ACTIVE FIXATION RELIANCE IS-1/4-SITE LEADS.
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