RIATA LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES
FDA premarket approval P950022/S032 · decided 2006-12-14
Approval details
- PMA number
- P950022
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RIATA LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-11-02
- Decision date
- 2006-12-14
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A HELIX ATTACHMENT MODIFICATION FOR THE RIATA 1580, 1581 AND 1582 LEADS AS WELL AS A CRIMP-WELD COUPLING MODIFICATION FOR THE RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES.
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