Durata and Optisure Leads (HV Active and Passive)
FDA premarket approval P950022/S102 · decided 2018-04-02
Approval details
- PMA number
- P950022
- Supplement
- S102
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Durata and Optisure Leads (HV Active and Passive)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-02-17
- Decision date
- 2018-04-02
- Days to decision
- 409 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for an alternate supplier for material used for lead insulation tubing.
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