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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 HPV HR AND GENFIND KIT
Generic Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
250 campus drive
marlborough, MA 01750
PMA NumberP080014
Supplement NumberS018
Date Received07/31/2013
Decision Date04/29/2014
Product Code MAQ 
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE.
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