PMA P020036S040
- Device
- Cordis S.M.A.R.T. CONTROL Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S040
- Product code
- NIO
- Decision date
- 2019-04-30
- Classification
- Stent, Iliac
- Generic name
- STENT, ILIAC
- 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 Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P020036
- Supplement
- S040
- Product code
- NIO
- Generic name
- STENT, ILIAC
- 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.