Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System
FDA premarket approval P120002/S017 · decided 2020-05-29
Approval details
- PMA number
- P120002
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Cordis US Corporation
- Date received
- 2020-05-01
- Decision date
- 2020-05-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility.
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