PMA P120002S016
- Device
- S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S016
- Product code
- NIP
- Decision date
- 2019-06-21
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Transfer of Final Release activities from the Cordis Miami Lakes site to the Cordis de Mexico site.
Current openFDA PMA Record#
- Device
- S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S016
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2019-06-21
- Decision code
- OK30
- Date received
- 2019-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of Final Release activities from the Cordis Miami Lakes site to the Cordis de Mexico site.