PMA P030004

Device: Onyx™ Liquid Embolic System (Onyx™ LES)
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S029
Product code: MFE
Decision date: 2026-10-14
Generic name: Agent, injectable, embolic
Approval order statement: Approval of the protocol for the Real-World Use Surveillance post-approval study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P030004/S035.

Current openFDA PMA Record#

Device: Onyx™ Liquid Embolic System (Onyx™ LES)
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S039
Product code: MFE
Generic name: Agent, injectable, embolic
Decision date: 2026-10-14
Decision code: APPR
Date received: 2026-01-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the Real-World Use Surveillance post-approval study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P030004/S035.