PMA P020036S029
- Device
- CORDIS SMART CONTROL NITINOL STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S029
- Product code
- NIO
- Decision date
- 2014-06-13
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- Approval order statement
- IMPLEMENTATION OF A NEW ULTRASONIC WELDER TO BE USED BY THE SUPPLIER OF THE HEMOSTASIS VALVE OF THE SLIDER ASSEMBLY.
Current openFDA PMA Record#
- Device
- CORDIS SMART CONTROL NITINOL STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S029
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2014-06-13
- Decision code
- OK30
- Date received
- 2014-05-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A NEW ULTRASONIC WELDER TO BE USED BY THE SUPPLIER OF THE HEMOSTASIS VALVE OF THE SLIDER ASSEMBLY.