ENDOTAK: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS
FDA premarket approval P910073/S038 · decided 2002-01-11
Approval details
- PMA number
- P910073
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2001-11-21
- Decision date
- 2002-01-11
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE PEEK SUPPORT CLIP FOR THE ENDOTAK DSP LEAD MODELS 0094, 0095, 0125, ENDOTAK ENDURANCE LEAD MODELS 0134, 0135, 0136 AND ENDOTAK ENDURANCE EZ LEAD MODELS 0154, 0155 AND 0156.
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