RELIANCE FAMILY ACTIVE FIXATION TACHY LEADS
FDA premarket approval P910073/S075 · decided 2008-11-07
Approval details
- PMA number
- P910073
- Supplement
- S075
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIANCE FAMILY ACTIVE FIXATION TACHY LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2008-09-12
- Decision date
- 2008-11-07
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A LUMEN SEAL MODIFICATION ON ENDOTAK RELIANCE, RELIANCE S, RELIANCE G, AND RELIANCE SG LEAD FAMILIES.
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