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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
Generic Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
250 campus drive
marlborough, MA 01750
PMA NumberP080014
Supplement NumberS012
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 HR V5.4 TO CERVISTA HPV HR V6.0.
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