FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Shunt, Portosystemic, Endoprosthesis
PMA: P040027
·
Supplement: S007
·
Decision Apr 11, 2008
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Shunt, Portosystemic, Endoprosthesis
- Trade Name
- GORE VIATORR TIPS ENDOPROTHESIS
- PMA Number
- P040027
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- MIR
- Generic Name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 11, 2008
- Date Received
- September 12, 2007
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.
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 |
|---|---|---|---|
| MIR | Shunt, Portosystemic, Endoprosthesis | FDA class 3 | Unknown |