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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 Drive
Marlborough, MA 01752
PMA NumberP020002
Supplement NumberS007
Date Received01/30/2014
Decision Date04/29/2014
APCB Date 03/22/2017
Product Code MNM 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF THE THINPREP® IMAGER DUO IMAGING STATION, HARDWARE (CAMERA AND EXTERIOR HOUSING) CHANGES, AND ASSOCIATED SOFTWARE CHANGES.
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