ONYX LIQUID EMBOLIC SYSTEM
FDA premarket approval P030004 · decided 2005-07-21
Approval details
- PMA number
- P030004
- Trade name
- ONYX LIQUID EMBOLIC SYSTEM
- Generic name
- Agent, injectable, embolic
- Applicant
- Ev3 Neurovascular
- Date received
- 2003-03-18
- Decision date
- 2005-07-21
- Days to decision
- 856 days
- Decision code
- APPR
- Product code
- MFE
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ONYX LIQUID EMBOLIC SYSTEM (LES). THE DEVICE IS INDICATED FOR PRESURGICAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |