ENDOTAK(R) LEAD SYSTEM
FDA premarket approval P910073/S018 · decided 1996-04-02
Approval details
- PMA number
- P910073
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK(R) LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-09-01
- Decision date
- 1996-04-02
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LEAD ADAPTER MODELS 6024, 6833, 6931
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