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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 drive
marlborough, MA 01752
PMA NumberP080015
Supplement NumberS007
Date Received04/17/2012
Decision Date05/21/2012
Product Code MAQ 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A SOFTWARE REVISION CHANGE FROM CERVISTA HPV 16/18 V5.4 TO CERVISTA HPV 16/18 V6.0.
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