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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.
DeviceAptima HPV 16 18/45 Genotype Assay
Generic Namekit, rna detection, human papillomavirus
10210 genetic center drive
san diego, CA 92121
PMA NumberP120007
Supplement NumberS011
Date Received09/01/2017
Decision Date02/23/2018
Product Code OYB 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the use of the Aptima HPV 16 18/45 Genotype Assay on Panther Systems equipped with a Panther Fusion Module. The changes required for addition of the Panther Fusion Module that are subject to this approval include reconfiguration of the Panther System hardware, and updates to the Panther System and Aptima HPV 16 18/45 Genotype Assay software.