PMA P020036S044
- Device
- Cordis S.M.A.R.T. CONTROL Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S044
- Product code
- NIO
- Decision date
- 2021-04-01
- Generic name
- STENT, ILIAC
- Approval order statement
- Implementing recertification procedures for returned stents.
Current openFDA PMA Record#
- Device
- Cordis S.M.A.R.T. CONTROL Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S044
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2021-04-01
- Decision code
- OK30
- Date received
- 2021-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing recertification procedures for returned stents.