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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCERVISTA
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
PMA NumberP080015
Supplement NumberS003
Date Received01/18/2011
Decision Date02/03/2011
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for several changes to the cervista hpv 16/18 software and labeling. Changes include the company name change from third wave to hologic, numerous user interface changes, and separating the invader call reporter and cervista hpv 16/18 software on to separate cds with new part numbers.
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