Onyx Liquid Embolic System (LES)
FDA premarket approval P030004/S035 · decided 2025-12-08
Approval details
- PMA number
- P030004
- Supplement
- S035
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Onyx Liquid Embolic System (LES)
- Generic name
- Neurovascular Liquid Embolic Agent
- Applicant
- Ev3 Neurovascular
- Date received
- 2024-10-15
- Decision date
- 2025-12-08
- Days to decision
- 419 days
- Decision code
- APPR
- Product code
- SGU
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- 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).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MERIDIAN GUIDEWIRE (K093681) | Ev3 Neurovascular | 2010-01-26 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 (K091458) | Ev3 Neurovascular | 2009-10-15 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 (K092495) | Ev3 Neurovascular | 2009-09-22 |