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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 HPV HR
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC LP
PMA NumberP080014
Supplement NumberS012
Date Received04/17/2012
Decision Date05/21/2012
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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