ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS
FDA premarket approval P910073/S025 · decided 1999-01-27
Approval details
- PMA number
- P910073
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-07-30
- Decision date
- 1999-01-27
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the Models 0144, 0145 and 0146 endocardial defibrillation leads. The device, as modified, will be marketed under the trade name ENDOTAK(R) ENDURANCE (Rx(TM)) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for VENTAK AICD automatic implantable cardioverter defibrillator systems.
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