FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Agent, Injectable, Embolic
PMA: P030004
·
Supplement: S011
·
Decision Sep 20, 2016
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Agent, Injectable, Embolic
- Trade Name
- ONYX LIQUID EMBOLIC SYSTEM
- PMA Number
- P030004
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- MFE
- Generic Name
- Agent, injectable, embolic
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 20, 2016
- Date Received
- June 22, 2016
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for minor packaging, sterilization and labeling changes to the Onyx 18 and 34 Kits.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MFE | Agent, Injectable, Embolic | FDA class 3 | Unknown |