Xvivo Perfusion System (XPS) with Steen Solution Perfusate

FDA Premarket Approval P180014 S003

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 for a software upgrade for the xps system (software version v. 5. 2. 0).

DeviceXvivo Perfusion System (XPS) with Steen Solution Perfusate
Generic NameNormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
ApplicantXVIVO Perfusion, Inc.
Date Received2020-01-27
Decision Date2020-04-24
Product CodePHO 
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address XVIVO Perfusion, Inc. 3666 S. Inca Street englewood, CO 80110

Supplemental Filings

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

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