PMA P020036S021
- Device
- S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S021
- Product code
- NIO
- Decision date
- 2011-12-05
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MATERIAL COMPOSITION OF THE TUBING IN THE HEMOSTASIS VALVE.
Current openFDA PMA Record#
- Device
- S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S021
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2011-12-05
- Decision code
- APPR
- Date received
- 2011-02-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MATERIAL COMPOSITION OF THE TUBING IN THE HEMOSTASIS VALVE.