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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
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP080015
Supplement NumberS002
Date Received11/29/2010
Decision Date03/29/2011
Withdrawal Date04/19/2023
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE INCREASE OF THE VOLUME OF THE HPV CONTROL IN CERVISTA HPB 16/18 TEST AND LABELING CHANGES TO THE PACKAGE INSERT.
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