PMA P030004S006
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S006
- Product code
- MFE
- Decision date
- 2014-05-27
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- APPROVAL FOR THE APOLLO ONYX DELIVERY MICRO CATHETER THAT WILL BE MANUFACTURED AT MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR IN IRVINE, CALIFORNIA.
Current openFDA PMA Record#
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S006
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2014-05-27
- Decision code
- APPR
- Date received
- 2013-04-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE APOLLO ONYX DELIVERY MICRO CATHETER THAT WILL BE MANUFACTURED AT MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR IN IRVINE, CALIFORNIA.