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Organ Care System (OCS™) Lung System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
TransMedics, Inc
Trade Name
Organ Care System (OCS™) Lung System
Generic Name
Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision Date
3/22/2018
Days to Decision
693 days
Decision Code
APPR
FDA Decision
Approval

Organ Care System (OCS™) Lung System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
TransMedics, Inc
Trade Name
Organ Care System (OCS™) Lung System
Generic Name
Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision Date
3/22/2018
Days to Decision
693 days
Decision Code
APPR
FDA Decision
Approval