PMA P120002S011
- Device
- CORDIS S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S011
- Product code
- NIP
- Decision date
- 2015-11-05
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- A CHANGE TO THE MANUFACTURING LOCATION OF YOUR SUPPLIER FOR THE INTERNAL PACKAGING POUCHES.
Current openFDA PMA Record#
- Device
- CORDIS S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S011
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2015-11-05
- Decision code
- OK30
- Date received
- 2015-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A CHANGE TO THE MANUFACTURING LOCATION OF YOUR SUPPLIER FOR THE INTERNAL PACKAGING POUCHES.