Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ Vascular Stent System
FDA premarket approval P120002/S024 · decided 2023-07-27
Approval details
- PMA number
- P120002
- Supplement
- S024
- 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, Cordis® S.M.A.R.T. RADIANZ Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Cordis US Corporation
- Date received
- 2023-06-29
- Decision date
- 2023-07-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Reduction of ethylene oxide concentration for the sterilization cycle.
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