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

• Device: XVIVO Perfusion System with STEEN Solution Perfusate
• Generic Name: Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
• Applicant: XVIVO Perfusion, Inc.
• Date Received: 2020-09-23
• Decision Date: 2020-10-23
• PMA: P180014
• Supplement: S005
• Product Code: PHO
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• 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