PMA P030004S020
- Device
- Onyx Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S020
- Product code
- MFE
- Decision date
- 2019-07-24
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Change to the Biological Indicator (BI) Bacillus atrophaeus STN 062MG that is used in the dry heat sterilization of the Onyx Liquid Embolic System.
Current openFDA PMA Record#
- Device
- Onyx Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S020
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2019-07-24
- Decision code
- OK30
- Date received
- 2019-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the Biological Indicator (BI) Bacillus atrophaeus STN 062MG that is used in the dry heat sterilization of the Onyx Liquid Embolic System.