PMA P120002S015
- Device
- Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S015
- Product code
- NIP
- Decision date
- 2019-04-30
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Process improvement to upgrade the sterilization vessel control system and associated mechanical components.
Current openFDA PMA Record#
- Device
- Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S015
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2019-04-30
- Decision code
- OK30
- Date received
- 2019-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process improvement to upgrade the sterilization vessel control system and associated mechanical components.