FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Agent, Injectable, Embolic
PMA: P030004
·
Supplement: S002
·
Decision Nov 29, 2006
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
- S002
- 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
- November 29, 2006
- Date Received
- May 19, 2006
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
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 |