PMA P030004S010
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S010
- Product code
- MFE
- Decision date
- 2016-03-31
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Additional sterilization chambers for the Apollo Onyx Delivery Microcatheter.
Current openFDA PMA Record#
- Device
- ONYX LIQUID EMBOLIC SYSTEM
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S010
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2016-03-31
- Decision code
- OK30
- Date received
- 2016-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional sterilization chambers for the Apollo Onyx Delivery Microcatheter.