ENDOTAK(R) LEAD SYSTEM
FDA premarket approval P910073/S015 · decided 1995-11-27
Approval details
- PMA number
- P910073
- Supplement
- S015
- 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
- 1995-05-01
- Decision date
- 1995-11-27
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE DECREASE IN THE LEAD BODY DIAMETER TO BE A MAXIMUM DIAMETER OF 10 FRENCH AND MODIFICATIONS IN THE LEAD COMPONENTS - THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK DSP LEAD MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125
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