DURATA, RIATA ST OPTIM, RIATA ST, RIATA 8F
FDA premarket approval P950022/S052 · decided 2008-09-18
Approval details
- PMA number
- P950022
- Supplement
- S052
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURATA, RIATA ST OPTIM, RIATA ST, RIATA 8F
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-05-07
- Decision date
- 2008-09-18
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A LABELING CHANGE TO ADD A PRECAUTION AGAINST USE OF DURATA LEADS WITH THE ST. JUDE MEDICAL SEAL AWAY VALVE.
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