PMA P030004S022
- Device
- Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S022
- Product code
- MFE
- Decision date
- 2019-12-19
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Changes to packaging operations and qualification of additional heat sealing equipment.
Current openFDA PMA Record#
- Device
- Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S022
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2019-12-19
- Decision code
- OK30
- Date received
- 2019-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to packaging operations and qualification of additional heat sealing equipment.