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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 HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC LP
PMA NumberP080014
Supplement NumberS010
Date Received12/28/2011
Decision Date01/20/2012
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to replace quality control test method controls with new quality control test method controls from the same supplier for incoming materials inspection testing and in-process quality control testing of accessory kit reagents.
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