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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 IMAGING SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP020002
Supplement NumberS002
Date Received03/30/2006
Decision Date04/28/2006
APCB Date03/22/2017
Product Code MNM 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE AND LABELING MODIFICATIONS OF THE THINPREP IMAGING SYSTEM FOR REMOTE REVIEWING CAPABILITY & LABELING CHANGE FOR THE THINPREP IMAGING SYSTEM TO INCORPORATE A NEW LIMITATION FOR SPECIMEN REPROCESSING.
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