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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTHINPREP(R) PROCESSOR, MODEL TP 2000
Generic NameProcessor, cervical cytology slide, automated
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP950039
Date Received11/22/1995
Decision Date05/20/1996
Product Code MKQ 
Docket Number 97M-0254
Notice Date 06/30/1997
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE THINPREP 2000 SYSTEM
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S020 S021 S024 S026 S027 
S028 S029 S030 S031 S032 S034 S035 S036 S037 S038 S039 S040 
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