ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR
FDA premarket approval P030004/S009 · decided 2015-12-18
Approval details
- PMA number
- P030004
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR
- Generic name
- Agent, injectable, embolic
- Applicant
- Ev3 Neurovascular
- Date received
- 2015-11-18
- Decision date
- 2015-12-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MFE
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- THE ADDITION OF CLARIFICATION TO THE COATING PROCEDURE REGARDING THE TOP COAT CURING TIME AND THE INCLUSION OF AN ADDITIONAL WEIGHING BALANCE TO THE COATING PREPARATION PROCEDURE FOR THE APOLLO ONYX DELIVERY MICRO CATHETER.
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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 |