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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 NumberS022
Date Received06/21/2019
Decision Date12/16/2019
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 addition of a Multi-tube unit (MTU) sidecar, Continuous Fluids Module, Waste-to-Drain Module, and Shuttle Module to the Panther and Panther Fusion instruments.