RIATA DEFIBRILLATION LEAD FAMILY
FDA premarket approval P950022/S018 · decided 2004-04-21
Approval details
- PMA number
- P950022
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RIATA DEFIBRILLATION LEAD FAMILY
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2004-03-11
- Decision date
- 2004-04-21
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATION TO THE RIATA DEFIBRILLATION LEAD FAMILY TO INCLUDE INTEGRATED BIPOLAR LEADS (MODELS 1560, 1561, 1562, 1590, 1591 AND 1592).
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