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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 5000 Processor
Generic NameProcessor, cervical cytology slide, automated
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP950039
Supplement NumberS038
Date Received06/05/2019
Decision Date09/03/2019
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for software upgrade to the ThinPrep 5000 processor
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