RIATA DEFIBRILLATION LEAD SYSTEM MODEL 1572 AND 1582
FDA premarket approval P950022/S016 · decided 2003-03-25
Approval details
- PMA number
- P950022
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RIATA DEFIBRILLATION LEAD SYSTEM MODEL 1572 AND 1582
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2002-12-31
- Decision date
- 2003-03-25
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR SINGLE DEFIBRILLATION COIL LEAD MODELS 1572 AND 1582.
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