PMA P020036S020
- Device
- SMART & SMART CONTROL NITINOL STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S020
- Product code
- NIO
- Decision date
- 2011-01-31
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TEMPERATURE SET POINT IN YOUR SUB- ASSEMBLY PROCESS.
Current openFDA PMA Record#
- Device
- SMART & SMART CONTROL NITINOL STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S020
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2011-01-31
- Decision code
- APPR
- Date received
- 2010-08-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TEMPERATURE SET POINT IN YOUR SUB- ASSEMBLY PROCESS.