PMA P120002S032
- Device
- S.M.A.R.T.® CONTROL® Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S032
- Product code
- NIP
- Decision date
- 2025-09-12
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- an additional supplier of the packaging tray and minor geometry modifications
Current openFDA PMA Record#
- Device
- S.M.A.R.T.® CONTROL® Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S032
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2025-09-12
- Decision code
- OK30
- Date received
- 2025-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional supplier of the packaging tray and minor geometry modifications