FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Shunt, Portosystemic, Endoprosthesis
PMA: P930031
·
Supplement: S074
·
Decision Feb 20, 2024
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Shunt, Portosystemic, Endoprosthesis
- Trade Name
- Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System
- PMA Number
- P930031
- Supplement Number
- S074
- 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
- February 20, 2024
- Date Received
- September 6, 2023
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an alternate supplier of an ingredient used to make the resin for the tapered tips and luer connector of all Wallstent delivery 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 |