ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS
FDA premarket approval P910073/S036 · decided 2000-10-12
Approval details
- PMA number
- P910073
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-07-06
- Decision date
- 2000-10-12
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODEL 6888 LEAD TUNNELER KIT AFTER REPLACING TUNNELING TIP MODEL 6995 WITH MODEL 6804 (USED WITH THE ENDOTAK RELIANCE / RELIANCE S LEADS
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