PMA P030004S002
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S002
- Product code
- MFE
- Decision date
- 2006-11-29
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
Current openFDA PMA Record#
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S002
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2006-11-29
- Decision code
- APPR
- Date received
- 2006-05-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.