PMA P020036S022
- Device
- S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM FOR USE IN LLIAC ARTERIES
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S022
- Product code
- NIO
- Decision date
- 2012-02-06
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- USE OF NEW EQUIPMENT FOR THE UV BONDING PROCESS.
Current openFDA PMA Record#
- Device
- S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM FOR USE IN LLIAC ARTERIES
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S022
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2012-02-06
- Decision code
- OK30
- Date received
- 2012-01-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF NEW EQUIPMENT FOR THE UV BONDING PROCESS.