XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate

FDA Premarket Approval P180014 S009

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

• 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.3666 S. Inca Streetenglewood, CO 80110 PMA NumberP180014 Supplement NumberS009 Date Received02/08/2022 Decision Date05/09/2022 Product Code PHO Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Date Received: 2022-02-08
• Decision Date: 2022-05-09
• PMA: P180014
• Supplement: S009
• 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 PMA NumberP180014 Supplement NumberS009 Date Received02/08/2022 Decision Date05/09/2022 Product Code PHO Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement ; Your Supplement Requested Approval For A XPS Hardware Update To Replace Obsoleted Pump Components With The Manufacturer’s Recommended New Model Components.

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