PMA P120002S023
- Device
- Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems
- Applicant
- Cordis US Corporation
- Product code
- NIP
- Decision date
- 2022-12-16
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- In-source polytetrafluorethylene (PTFE) component manufacturing.
Current openFDA PMA Record
- Device
- Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S023
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-12-16
- Decision code
- OK30
- Date received
- 2022-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- In-source polytetrafluorethylene (PTFE) component manufacturing.