XVIVO Perfusion System with STEEN Solution Perfusate

FDA Premarket Approval P180014 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p180014

DeviceXVIVO Perfusion System with STEEN Solution Perfusate
Generic NameNormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
ApplicantXVIVO Perfusion, Inc.
Date Received2020-09-23
Decision Date2020-10-23
PMAP180014
SupplementS005
Product CodePHO 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product Yes
Applicant Address XVIVO Perfusion, Inc. 3666 S. Inca Street englewood, CO 80110

Supplemental Filings

Supplement NumberDateSupplement Type
P180014Original Filing
S005 2020-09-23 Normal 180 Day Track No User Fee
S004 2020-01-27 Real-time Process
S003 2020-01-27 Real-time Process
S002
S001 2019-05-28 Normal 180 Day Track No User Fee

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