Optisure High Voltage Leads
FDA premarket approval P950022/S131 · decided 2020-05-15
Approval details
- PMA number
- P950022
- Supplement
- S131
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Optisure High Voltage Leads
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-03-12
- Decision date
- 2020-05-15
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) and to discontinue the Externalization and Abrasion sub-study.
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