FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Shunt, Portosystemic, Endoprosthesis
PMA: P930031
·
Supplement: S054
·
Decision Aug 12, 2015
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Shunt, Portosystemic, Endoprosthesis
- Trade Name
- WALLSTENT ENDOPROSTHESIS TIPS
- PMA Number
- P930031
- Supplement Number
- S054
- 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
- August 12, 2015
- Date Received
- March 9, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE IN DEVICE LABELING FROM MR SAFE TO MR CONDITIONAL.
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 |