PMA P030004S027
- Device
- Onyx™ Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S027
- Product code
- MFE
- Decision date
- 2021-09-16
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Approval for the inclusion of radial access considerations in the Onyx Liquid Embolic System labeling.
Current openFDA PMA Record#
- Device
- Onyx™ Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S027
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2021-09-16
- Decision code
- APPR
- Date received
- 2021-05-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the inclusion of radial access considerations in the Onyx Liquid Embolic System labeling.