PMA P020036S054
- Device
- S.M.A.R.T. CONTROL Nitinol Stent System; S.M.A.R.T. RADIANZ Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S054
- Product code
- NIO
- Decision date
- 2025-04-09
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- approval of new deionized water purification equipment
Current openFDA PMA Record#
- Device
- S.M.A.R.T. CONTROL Nitinol Stent System; S.M.A.R.T. RADIANZ Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S054
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-04-09
- Decision code
- OK30
- Date received
- 2025-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of new deionized water purification equipment