FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Shunt, Portosystemic, Endoprosthesis
PMA: P930031
·
Supplement: S003
·
Decision Jan 3, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Shunt, Portosystemic, Endoprosthesis
- Trade Name
- WALLSTENT(R) TIPS ENDOPROSTHESIS
- PMA Number
- P930031
- Supplement Number
- S003
- 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
- January 3, 1997
- Date Received
- May 13, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFYING THE WIRE DIAMETER AND NUMBER OF WIRES IN THE 12 MM DIAMETER STENT, AND CORRECTS THE ACTUAL LENGTH TO BE MARKETED.
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 |