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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.
 
DeviceCOLOGUARD
Generic Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Applicant
Exact Sciences Corporation
441 charmany drive
madison, WI 53719
PMA NumberP130017
Supplement NumberS005
Date Received12/04/2015
Decision Date12/23/2015
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 THE FOLLOWING: USE OF SOFTWARE SPREADSHEET WORKBOOK FOR AUTOMATED DATA PROCESSING IN PLACE OF MANUAL CALCULATIONS OF ACCEPTANCE CRITERIA FOR QUALITYCONTROL (QC) TEST; REVISION OF THE UPPER SPECIFICATION LIMIT FOR QC BLANK POSITIVITY FOR MARKERSBTACT AND ACT; RELOCATION OF THE QC LABORATORIES FROM THE FIRST FLOOR TO THE SECOND FLOORWITHIN THE SAME FACILITY; AND RELOCATION OF THE LABELING AND DISPENSING ACTIVITIES INTO OTHER ROOMSON THE SAME FLOOR.
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