FDA.reportPublic FDA data

PMA P180051S003

Device
Organ Care System (OCS) Heart System
Applicant
TransMedics, Inc.
PMA number
P180051
Supplement
S003
Product code
QIK
Decision date
2023-05-09
Classification
Cardiovascular
Generic name
Organ care system (OCS) heart system
Approval order statement
Approval for a change to the wireless monitor of the OCS Lung System, including replacing the obsolete display panel with an updated panel, replacing the existing CCFL backlight driver with an LED backlight driver, updating the Wireless Monitor PCBA with minor component updates.

Current openFDA PMA Record#

Device
Organ Care System (OCS) Heart System
Applicant
TransMedics, Inc.
PMA number
P180051
Supplement
S003
Product code
QIK
Generic name
Organ care system (OCS) heart system
Decision date
2023-05-09
Decision code
APPR
Date received
2023-03-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the wireless monitor of the OCS Lung System, including replacing the obsolete display panel with an updated panel, replacing the existing CCFL backlight driver with an LED backlight driver, updating the Wireless Monitor PCBA with minor component updates.