FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Shunt, Portosystemic, Endoprosthesis
PMA: P040027
·
Supplement: S074
·
Decision Feb 28, 2020
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Shunt, Portosystemic, Endoprosthesis
- Trade Name
- GORE VIATORR TIPSEndoprosthesis product family
- PMA Number
- P040027
- 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 28, 2020
- Date Received
- September 3, 2019
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval of a new ethylene oxide sterilization cycle to pe performed at a new sterilization site (Sterigenics US, LLC located at 4900 Gifford Ave. Los Angeles, CA).
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 |