PMA P020036S058
- Device
- S.M.A.R.T.® CONTROL® Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S058
- Product code
- NIO
- Decision date
- 2025-12-04
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- an alternate supplier for bismuth sub carbonate (BSC) for the catheter tip
Current openFDA PMA Record#
- Device
- S.M.A.R.T.® CONTROL® Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S058
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-12-04
- Decision code
- OK30
- Date received
- 2025-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate supplier for bismuth sub carbonate (BSC) for the catheter tip