Durata and Optisure Leads
FDA premarket approval P950022/S119 · decided 2018-06-27
Approval details
- PMA number
- P950022
- Supplement
- S119
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Durata and Optisure Leads
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-04-02
- Decision date
- 2018-06-27
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for a shelf life extension for the Durata (Models 7120Q, 7121Q, 7122Q) and Optisure (Models LDA210Q, LDA220Q, LDA230Q) leads from 12 months to 36 months.
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