Durata and Optisure High Voltage Lead
FDA premarket approval P950022/S110 · decided 2017-10-18
Approval details
- PMA number
- P950022
- Supplement
- S110
- 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
- 2017-07-28
- Decision date
- 2017-10-18
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for extending the length of the helix shaft and modifying the crimping components at the shock coil(s) and ring electrode.
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