PMA P120002
- Device
- S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S022
- Product code
- NIP
- Decision date
- 2026-01-08
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- approval to change the receiving inspection level for 15 part numbers
Current openFDA PMA Record#
- Device
- S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S034
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2026-01-08
- Decision code
- OK30
- Date received
- 2025-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to change the receiving inspection level for 15 part numbers