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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.
 
DeviceMONOPREP PAP TEST
Generic NameProcessor, cervical cytology slide, automated
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP040052
Date Received12/30/2004
Decision Date03/03/2006
Withdrawal Date 03/21/2017
Product Code MKQ 
Docket Number 06M-0264
Notice Date 06/26/2006
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MONOPREP PAP TEST (MPPT). THE DEVICE IS INTENDED FOR USE IN COLLECTING AND PREPARING CERVICAL-VAGINAL CYTOLOGY SPECIMENS FOR PAP STAIN-BASED SCREENING FOR CERVICAL CANCER, IT'S PRECURSOR LESIONS, AND OTHER CYTOLOGICAL CATEGORIES AND CONDITIONS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY. THE MONOPREP PAP TEST PRODUCES SLIDES THAT ARE INTENDED TO REPLACE CONVENTIONALLY PREPARED PAP SMEAR SLIDES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 S005 S006 S007 S008 
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