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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 NumberS009
Date Received10/16/2014
Decision Date01/12/2015
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 MODIFICATIONS TO THE REVIEW SCOPE MANUAL PLUS MICROSCOPE FRAME OF THE THINPREP IMAGING SYSTEM.
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