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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
ApplicantNew Day Diagnostics, LLC
6701 Baum Dr.
Suite 110
Knoxville, TN 37919
PMA NumberP130001
Supplement NumberS004
Date Received02/20/2018
Decision Date03/20/2018
Product Code PHP 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of alternate suppliers of key reagents for the test system.
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