PMA P030004S025
- Device
- Onyx Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S025
- Product code
- MFE
- Decision date
- 2020-11-13
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Manufacturing location of the supplier of EVOH (ethylene vinyl alcohol) for Onyx Liquid Embolic System from Japan to Belgium to increase the production capacity.
Current openFDA PMA Record#
- Device
- Onyx Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S025
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2020-11-13
- Decision code
- OK30
- Date received
- 2020-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing location of the supplier of EVOH (ethylene vinyl alcohol) for Onyx Liquid Embolic System from Japan to Belgium to increase the production capacity.