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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceEpi proColon
Generic Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Applicant
EPIGENOMICS AG
geneststr.5
berlin 
PMA NumberP130001
Supplement NumberS005
Date Received08/06/2019
Decision Date08/30/2019
Product Code PHP 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of storage and distribution facility.
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