ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD
FDA premarket approval P910073/S028 · decided 2000-04-20
Approval details
- PMA number
- P910073
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-01-11
- Decision date
- 2000-04-20
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for changes to the helix mechanism of the ENDOTAK ENDURANCE EZ Endocardial Defibrillation Lead.
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