PMA P020036S041
- Device
- S.M.A.R.T. AND S.M.A.R.T. CONTROL Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S041
- Product code
- NIO
- Decision date
- 2019-06-21
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- Transfer of Final Release activities from the Cordis Miami Lakes site to the Cordis de Mexico site.
Current openFDA PMA Record#
- Device
- S.M.A.R.T. AND S.M.A.R.T. CONTROL Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S041
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2019-06-21
- Decision code
- OK30
- Date received
- 2019-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of Final Release activities from the Cordis Miami Lakes site to the Cordis de Mexico site.