ENDOTAK ENDURANCE EZ ENDOCARDIAL DIFIBRILLATION LEAD
FDA premarket approval P910073/S026 · decided 1999-06-15
Approval details
- PMA number
- P910073
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK ENDURANCE EZ ENDOCARDIAL DIFIBRILLATION LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-03-19
- Decision date
- 1999-06-15
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- The device is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for AICS automatic implantable cardioverter defibrillator systems.
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