FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
PMA: P180014
·
Supplement: S004
·
Decision Apr 26, 2020
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
- Trade Name
- XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
- PMA Number
- P180014
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- PHO
- Generic Name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 26, 2020
- Date Received
- January 27, 2020
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a change in the ventilator included in the XPS System to use the Hamilton C3 Ventilator.
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 |
|---|---|---|---|
| PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | FDA class 3 | Unknown |