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: S027
• Date Received: 05/05/2021
• Decision Date: 09/16/2021
• Product Code: MFE
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the inclusion of radial access considerations in the Onyx Liquid Embolic System labeling.