Organ Care System (OCS) Heart System

FDA Premarket Approval P180051

Pre-market Approval Supplement Details

Approval for the organ care system (ocs) heart system. This device is indicated for the preservation of donor-after-brain-death (dbd) hearts 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).

DeviceOrgan Care System (OCS) Heart System
Generic NameOrgan Care System (ocs) Heart System
ApplicantTransMedics, Inc.
Date Received2018-12-26
Decision Date2021-09-03
PMAP180051
SupplementS
Product CodeQIK 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address TransMedics, Inc. 200 Minuteman Road, Suite 302 andover, MA 01810

Supplemental Filings

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Supplement NumberDateSupplement Type
P180051Original Filing

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