DURATA
FDA premarket approval P950022/S049 · decided 2008-01-10
Approval details
- PMA number
- P950022
- Supplement
- S049
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURATA
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-12-03
- Decision date
- 2008-01-10
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A TRADENAME CHANGE FROM RIATA STS OPTIM TO DURATA FOR LEAD MODELS 7120, 7121, 7122, 7130, 7131, 7170 AND 7171.
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