PMA P120002S004
- Device
- SMART CONTROL VASCULAR STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S004
- Product code
- NIP
- Decision date
- 2014-06-13
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- 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
- SMART CONTROL VASCULAR STENT SYSTEMS
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S004
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- 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.