PMA P020036S061
- Device
- S.M.A.R.T. ® CONTROL® Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S061
- Product code
- NIO
- Decision date
- 2026-10-15
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- approval for an alternate supplier of a Bismuth Sub Carbonate Blend used in the catheter outer member
Current openFDA PMA Record#
- Device
- S.M.A.R.T. ® CONTROL® Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S061
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2026-10-15
- Decision code
- OK30
- Date received
- 2026-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate supplier of a Bismuth Sub Carbonate Blend used in the catheter outer member