PMA P030004S035

Device: Onyx Liquid Embolic System (LES)
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S035
Product code: SGU
Decision date: 2025-12-08
Classification: Neurology
Generic name: Neurovascular Liquid Embolic Agent
Approval order statement: Onyx Liquid Embolic System (LES) is indicated 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: S035
Product code: SGU
Generic name: Neurovascular Liquid Embolic Agent
Decision date: 2025-12-08
Decision code: APPR
Date received: 2024-10-15
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Onyx Liquid Embolic System (LES) is indicated for embolization of the middle meningeal artery (MMA) as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma (SDH).