PMA P030004S005
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S005
- Product code
- MFE
- Decision date
- 2012-04-05
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND PATIENT BROCHURE THAT STRENGTHEN THE WARNINGS ABOUT CATHETER ENTRAPMENT.
Current openFDA PMA Record#
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S005
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2012-04-05
- Decision code
- APPR
- Date received
- 2012-01-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND PATIENT BROCHURE THAT STRENGTHEN THE WARNINGS ABOUT CATHETER ENTRAPMENT.