PMA P120002S005
- Device
- CORDIS SMART/SMART CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S005
- Product code
- NIP
- Decision date
- 2014-10-23
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- CHANGES TO OPTIMIZE THE POUCH SEALING PROCESS AS WELL AS A NEW POUCH SEALER.
Current openFDA PMA Record#
- Device
- CORDIS SMART/SMART CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S005
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2014-10-23
- Decision code
- OK30
- Date received
- 2014-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO OPTIMIZE THE POUCH SEALING PROCESS AS WELL AS A NEW POUCH SEALER.