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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 Genesis Processor
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS040
Date Received09/30/2020
Decision Date05/14/2021
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Hologic ThinPrep Genesis Processor.
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