ONYX LIQUID EMBOLIC SYSTEM
FDA premarket approval P030004/S005 · decided 2012-04-05
Approval details
- PMA number
- P030004
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ONYX LIQUID EMBOLIC SYSTEM
- Generic name
- Agent, injectable, embolic
- Applicant
- Ev3 Neurovascular
- Date received
- 2012-01-26
- Decision date
- 2012-04-05
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- MFE
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND PATIENT BROCHURE THAT STRENGTHEN THE WARNINGS ABOUT CATHETER ENTRAPMENT.
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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 |