FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Shunt, Portosystemic, Endoprosthesis
PMA: P040027
·
Supplement: S069
·
Decision Jan 2, 2019
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
- S069
- 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
- January 2, 2019
- Date Received
- December 7, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.
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 |