PMA P030004
- Device
- Onyx™ Liquid Embolic System (LES)
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S029
- Product code
- MFE
- Decision date
- 2026-04-29
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Approval for changes to the mixing time, packaging configuration, and sterilization process for the Onyx Liquid Embolic System (LES).
Current openFDA PMA Record#
- Device
- Onyx™ Liquid Embolic System (LES)
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S040
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2026-04-29
- Decision code
- APPR
- Date received
- 2026-01-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the mixing time, packaging configuration, and sterilization process for the Onyx Liquid Embolic System (LES).