PMA P030004S030
- Device
- Onyx™ Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S030
- Product code
- MFE
- Decision date
- 2023-11-03
- Classification
- Neurology
- Generic name
- Agent, injectable, embolic
- Approval order statement
- approval for the relocation of packaging supplier, House of Packaging, and associated thermoforming equipment change for the Onyx Liquid Embolic System
Current openFDA PMA Record#
- Device
- Onyx™ Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S030
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2023-11-03
- Decision code
- OK30
- Date received
- 2023-10-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the relocation of packaging supplier, House of Packaging, and associated thermoforming equipment change for the Onyx Liquid Embolic System