Durata, Optisure High Voltage Passive, High Voltage Active
FDA premarket approval P950022/S126 · decided 2018-12-17
Approval details
- PMA number
- P950022
- Supplement
- S126
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Durata, Optisure High Voltage Passive, High Voltage Active
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-11-30
- Decision date
- 2018-12-17
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Acquire curing trays and Teflon coating services from alternate suppliers for use in the curing process when creating Optim E2A resin pellets.
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