ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS
FDA premarket approval P910073/S027 · decided 1999-09-29
Approval details
- PMA number
- P910073
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-07-26
- Decision date
- 1999-09-29
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a modified DF-1 terminal of the ENDOTAK(R) series of Endocardial Defibrillation Leads and the Model 6952 Lead Extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition.
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