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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 16/18
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
PMA NumberP080015
Supplement NumberS008
Date Received06/11/2012
Decision Date07/06/2012
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 in the clinical development database software from version 5. 9 to version 6. 0.
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