PMA P160013S011
- Device
- Organ Care System (OCS™) Lung
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S011
- Product code
- QBA
- Decision date
- 2023-02-23
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Approval order statement
- Expand the clean room area at the existing manufacturing facility.
Current openFDA PMA Record#
- Device
- Organ Care System (OCS™) Lung
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S011
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2023-02-23
- Decision code
- OK30
- Date received
- 2023-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expand the clean room area at the existing manufacturing facility.