Durata and Optisure High Voltage Lead
FDA premarket approval P950022/S112 · decided 2020-05-17
Approval details
- PMA number
- P950022
- Supplement
- S112
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Durata and Optisure High Voltage Lead
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-10-23
- Decision date
- 2020-05-17
- Days to decision
- 937 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for single shock coil passive fixation lead models (Durata 7172Q and Optisure LDP210Q) and changes to the crimp subassemblies.
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