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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 DNA EXTENSION KIT
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH, MA 01750
PMA NumberP080014
Supplement NumberS003
Date Received09/16/2010
Decision Date10/06/2010
Withdrawal Date 04/19/2023
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SEVERAL CHANGES TO THE INVADER CALL REPORTER AND CERVISTA HPV HR SOFTWARE ON THE SEPARATE CDS WITH NEW PART NUMBERS.
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