OCS Heart System

FDA Premarket Approval P180051 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

DeviceOCS Heart System
Generic NameOrgan Care System (ocs) Heart System
ApplicantTransMedics, Inc.200 Minuteman Road, Suite 302andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK  Advisory Committee Cardiovascular Clinical TrialsNCT03831048 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2021-11-08
Decision Date2022-04-27
PMAP180051
SupplementS001
Product CodeQIK 
Advisory CommitteeCardiovascular
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressTransMedics, Inc.
200 Minuteman Road, Suite 302
andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK  Advisory Committee Cardiovascular Clinical TrialsNCT03831048
Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For The Organ Care System (OCS) Heart System For Expanding The Indication To Include Donation-after-circulatory-death (DCD) Donor Hearts. The Device Is Indicated For The Preservation Of Donation-after-brain-death (DBD) Hearts Initially Deemed Unsuitable For Procurement And Transplantation At Initial Evaluation Due To Limitations Of Prolonged Cold Static Cardioplegic Preservation (e.g., > 4 Hours Of Cross-clamp Time). The OCS Heart System Is Also Indicated For The Ex Vivo Reanimation, Functional Monitoring, And Beating-heart Preservation Of DCD Hearts.

Supplemental Filings

Supplement NumberDateSupplement Type
P180051Original Filing
S001 2021-11-08 Panel Track

NIH GUDID Devices

Device IDPMASupp
B00953975 P180051 000
B00913600 P180051 000
B00918043 P180051 000
B00924420 P180051 000
B00925721 P180051 000
B00925741 P180051 000
B00925751 P180051 000
B00926340 P180051 000
B00936363 P180051 000
B00936463 P180051 000
B00943661 P180051 000
B00948225 P180051 000
B00948913 P180051 000
B00949290 P180051 000
B00913390 P180051 000

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