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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 16/18 TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP080015
Supplement NumberS010
Date Received08/02/2013
Decision Date03/04/2014
Withdrawal Date 04/19/2023
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT GEN-PROBE INCORPORATED, SAN DIEGO, CALIFORNIA FOR THE MANUFACTURING OF THE CERVISTA HPV HR AND THE CERVISTA HPV 16/18.
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