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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
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS026
Date Received06/27/2013
Decision Date03/02/2015
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 THINPREP 5000 PROCESSOR.
Post-Approval StudyShow Report Schedule and Study Progress
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