FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
PMA: P180014
·
Decision Apr 26, 2019
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
- Trade Name
- XPS with Steen Solution Perfusate
- PMA Number
- P180014
- 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, 2019
- Date Received
- May 10, 2018
- Expedited Review
- N
- Docket Number
- 19M-2052
Advisory Committee Statement
Approval for the XPS with Steen Solution Perfusate. This device is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for transplantation.
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 |