PMA P030004S042

Device: Onyx™ Liquid Embolic System (LES)
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S042
Product code: MFE
Decision date: 2026-08-05
Classification: Neurology
Generic name: Agent, injectable, embolic
Approval order statement: Approval to add the Onyx 12 LES to the Onyx LES product line for embolization of the middle meningeal artery (MMA) as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma (SDH).

Current openFDA PMA Record#

Device: Onyx™ Liquid Embolic System (LES)
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S042
Product code: MFE
Generic name: Agent, injectable, embolic
Decision date: 2026-08-05
Decision code: APPR
Date received: 2026-03-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to add the Onyx 12 LES to the Onyx LES product line for embolization of the middle meningeal artery (MMA) as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma (SDH).