FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
PMA: P200031
·
Supplement: S002
·
Decision Feb 23, 2023
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
- Trade Name
- Organ Care System (OCS) Liver
- PMA Number
- P200031
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- QQK
- Generic Name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 23, 2023
- Date Received
- January 27, 2023
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Expand the clean room area at the existing manufacturing facility.
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 |
|---|---|---|---|
| QQK | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation | FDA class 3 | Unknown |