Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Onyx Liquid Embolic System
• Generic Name: Agent, injectable, embolic
• Applicant: Ev3 Neurovascular; 9775 Toledo Way; Irvine, CA 92618
• PMA Number: P030004
• Supplement Number: S018
• Date Received: 05/31/2019
• Decision Date: 06/06/2019
• Product Code: MFE
• Advisory Committee: Neurology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Remove mycoplasma testing from the incoming inspection acceptance criteria for non-sterile DMSO.