XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Premarket Approval P180014 S001

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 protocol for the post-approval study (pas) protocol.

DeviceXVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Classification NameNormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Generic NameNormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
ApplicantXVIVO Perfusion, Inc.
Date Received2019-05-28
Decision Date2019-10-29
PMAP180014
SupplementS001
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
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 IDPMASupp
07350069520500 P180014 000
07350069520401 P180014 000

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