S.M.A.R.T.® CONTROL® Nitinol Stent System
FDA premarket approval P020036/S057 · decided 2025-09-12
Approval details
- PMA number
- P020036
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- S.M.A.R.T.® CONTROL® Nitinol Stent System
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2025-08-26
- Decision date
- 2025-09-12
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- an additional supplier of the packaging tray and minor geometry modifications
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