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XPS™ with Steen Solution™ Perfusate

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
XVIVO Perfusion, Inc.
Trade Name
XPS™ with Steen Solution™ Perfusate
Generic Name
Normothermic preservation system for transplantation of initially unacceptable donor lungs
Decision Date
4/26/2019
Days to Decision
351 days
Decision Code
APPR
FDA Decision
Approval

XPS™ with Steen Solution™ Perfusate

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
XVIVO Perfusion, Inc.
Trade Name
XPS™ with Steen Solution™ Perfusate
Generic Name
Normothermic preservation system for transplantation of initially unacceptable donor lungs
Decision Date
4/26/2019
Days to Decision
351 days
Decision Code
APPR
FDA Decision
Approval