PMA P020036S048
- 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
- P020036
- Supplement
- S048
- Product code
- NIO
- Decision date
- 2022-12-16
- Generic name
- STENT, ILIAC
- 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
- P020036
- Supplement
- S048
- Product code
- NIO
- Generic name
- STENT, ILIAC
- 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.