Durata and Optisure leads
FDA premarket approval P950022/S095 · decided 2017-01-13
Approval details
- PMA number
- P950022
- Supplement
- S095
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Durata and Optisure leads
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-09-27
- Decision date
- 2017-01-13
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for changes to the extraction test method for steroid eluting leads.
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