PMA P030047S040
- Device
- Cordis PRECISE Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S040
- Product code
- NIM
- Decision date
- 2020-05-29
- Generic name
- Stent, carotid
- Approval order statement
- Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility.
Current openFDA PMA Record#
- Device
- Cordis PRECISE Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S040
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2020-05-29
- Decision code
- OK30
- Date received
- 2020-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility.