PMA P200031S009
- Device
- Organ Care System™ (OCS™) Liver
- Applicant
- TransMedics, Inc.
- PMA number
- P200031
- Supplement
- S009
- Product code
- QQK
- Decision date
- 2024-10-11
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Approval order statement
- change in manufacturing process
Current openFDA PMA Record#
- Device
- Organ Care System™ (OCS™) Liver
- Applicant
- TransMedics, Inc.
- PMA number
- P200031
- Supplement
- S009
- Product code
- QQK
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Decision date
- 2024-10-11
- Decision code
- OK30
- Date received
- 2024-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change in manufacturing process