PMA P030004S011
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S011
- Product code
- MFE
- Decision date
- 2016-09-20
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Approval for minor packaging, sterilization and labeling changes to the Onyx 18 and 34 Kits.
Current openFDA PMA Record#
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S011
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2016-09-20
- Decision code
- APPR
- Date received
- 2016-06-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor packaging, sterilization and labeling changes to the Onyx 18 and 34 Kits.