PMA P120002S009
- Device
- S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S009
- Product code
- NIP
- Decision date
- 2015-11-25
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- APPROVAL FOR REMOVAL OF PERFLUORO-OCTANOIC ACID (PFOA) FROM THE POLYTETRAFLUORO-ETHYLENE (PTFE) TUBING.
Current openFDA PMA Record#
- Device
- S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S009
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2015-11-25
- Decision code
- APPR
- Date received
- 2015-03-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR REMOVAL OF PERFLUORO-OCTANOIC ACID (PFOA) FROM THE POLYTETRAFLUORO-ETHYLENE (PTFE) TUBING.