PMA P030004S015
- Device
- Onyx Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S015
- Product code
- MFE
- Decision date
- 2018-06-06
- Classification
- Agent, Injectable, Embolic
- Generic name
- Agent, injectable, embolic
- Approval order statement
- Site change of the hydrophilic coating components supplier to expand its capacity and process efficiency.
Current openFDA PMA Record#
- Device
- Onyx Liquid Embolic System
- Applicant
- Ev3 Neurovascular
- PMA number
- P030004
- Supplement
- S015
- Product code
- MFE
- Generic name
- Agent, injectable, embolic
- Decision date
- 2018-06-06
- Decision code
- OK30
- Date received
- 2018-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Site change of the hydrophilic coating components supplier to expand its capacity and process efficiency.