ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187
FDA premarket approval P910073/S043 · decided 2004-03-02
Approval details
- PMA number
- P910073
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-12-04
- Decision date
- 2004-03-02
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ADDITION OF AN EPTFE COATING TO THE SHOCK COILS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK RELIANCE G/SG LEAD MODELS AND IS INDICATED FOR PROVIDING PACING AND RATE-SENSING AND TO DELIVER CARDIOVERSION AND DEFIBRILLATION SHOCKS FOR ICD AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS.
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