PMA P030004

Device: Onyx™ Liquid Embolic System (LES)
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S029
Product code: SGU
Decision date: 2026-08-05
Generic name: Neurovascular Liquid Embolic Agent
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: SGU
Generic name: Neurovascular Liquid Embolic Agent
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).