PMA P120002S018
- Device
- Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S018
- Product code
- NIP
- Decision date
- 2020-10-23
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Replace a supplier's winding equipment used to manufacture a component of the delivery system.
Current openFDA PMA Record#
- Device
- Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S018
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2020-10-23
- Decision code
- OK30
- Date received
- 2020-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a supplier's winding equipment used to manufacture a component of the delivery system.