PMA P020036S045
- Device
- S.M.A.R.T. RADIANZ Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S045
- Product code
- NIO
- Decision date
- 2022-02-25
- Generic name
- STENT, ILIAC
- Approval order statement
- Approval for a new delivery system to allow use with a transradial approach.
Current openFDA PMA Record#
- Device
- S.M.A.R.T. RADIANZ Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S045
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2022-02-25
- Decision code
- APPR
- Date received
- 2021-09-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new delivery system to allow use with a transradial approach.