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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, GENFIND DNA EXTRACTION KIT
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH, MA 01750
PMA NumberP080014
Supplement NumberS015
Date Received12/19/2012
Decision Date04/18/2013
Withdrawal Date 04/19/2023
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MINOR LABELING CHANGE IN THE CERVISTA OPERATOR¿S MANUAL.
Post-Approval StudyShow Report Schedule and Study Progress
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