FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Shunt, Portosystemic, Endoprosthesis
PMA: P040027
·
Supplement: S090
·
Decision Feb 22, 2022
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Shunt, Portosystemic, Endoprosthesis
- Trade Name
- GORE® VIATORR® TIPS Endoprosthesis
- PMA Number
- P040027
- Supplement Number
- S090
- Device Class
- FDA Class 3
- Product Code
- MIR
- Generic Name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 22, 2022
- Date Received
- January 20, 2022
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Removal of cytotoxicity and infrared spectroscopy inspections for incoming components.
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 |