PMA P030004
- Device
- Onyx ™ Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S029
- Product code
- MFE
- Decision date
- 2026-07-21
- Generic name
- Agent, injectable, embolic
- Approval order statement
- introduction of a new stir plate and modifications to processing parameters related to the stir plate settings used to manufacture the Onyx device
Current openFDA PMA Record#
- Device
- Onyx ™ Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S044
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2026-07-21
- Decision code
- OK30
- Date received
- 2026-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of a new stir plate and modifications to processing parameters related to the stir plate settings used to manufacture the Onyx device