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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NameHEARTSBREATH
Classification Nametest, volatile organic compounds breath analysis
Generic Nametest, volatile organic compounds breath analysis
Applicant
Menssana Research, Inc.
1 horizon rd.
suite 1415
fort lee, NJ 07024
HDE NumberH030004
Date Received08/18/2003
Decision Date02/24/2004
Product Code
PAR
Docket Number 04M-0084
Notice Date 02/24/2004
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the heartsbreath. This device is indicated for use as an aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. The heartsbreath test is intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
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