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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 Assay
Generic Namekit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
10210 genetic center drive
san diego, CA 92121
PMA NumberP100042
Supplement NumberS024
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.
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