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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.
 
DeviceCERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)
Generic Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
250 campus drive
marlborough, MA 01750
PMA NumberP080014
Supplement NumberS010
Date Received12/28/2011
Decision Date01/20/2012
Product Code MAQ 
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO REPLACE QUALITY CONTROL TEST METHOD CONTROLS WITH NEW QUALITY CONTROL TEST METHOD CONTROLS FROM THE SAME SUPPLIER FOR INCOMING MATERIALS INSPECTION TESTING AND IN-PROCESS QUALITY CONTROL TESTING OF ACCESSORY KIT REAGENTS.
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