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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 COMPONENTS
Generic Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
250 campus drive
marlborough, MA 01750
PMA NumberP080014
Supplement NumberS011
Date Received01/09/2012
Decision Date02/04/2013
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 SHELF-LIFE EXTENSION OF THE DEVICE FROM 12 MONTHS TO 18 MONTHS.
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