XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

FDA Premarket Approval P180014 S004

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 change in the ventilator included in the xps™ system to use the hamilton c3 ventilator

• Device: XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
• Generic Name: Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
• Applicant: XVIVO Perfusion, Inc.
• Date Received: 2020-01-27
• Decision Date: 2020-04-26
• PMA: P180014
• Supplement: S004
• Product Code: PHO
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: XVIVO Perfusion, Inc. 3666 S. Inca Street englewood, CO 80110

Supplemental Filings

Supplement Number	Date	Supplement Type
P180014		Original Filing
S009	2022-02-08	Real-time Process
S008	2022-02-08	Real-time Process
S007
S006	2021-10-04	Normal 180 Day Track No User Fee
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

NIH GUDID Devices

Device ID	PMA	Supp
07350069520500	P180014	000
07350069520401	P180014	000