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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.
 
DeviceThinPrep Integrated Imager
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP950039
Supplement NumberS036
Date Received07/31/2017
Decision Date04/18/2018
Product Codes MKQ MNM 
Docket Number 18M-1580
Notice Date 05/07/2018
Advisory Committee Pathology
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the Hologic ThinPrep® Integrated Imager. The device uses computer imaging technology to assist in primary cervical cancer screening of ThinPrep® Pap Test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma as well as all other cytologic criteria as defined by the Bethesda System: Terminology for Reporting Results of Cervical Cytology.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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