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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMONOPREP PAP TEST
Classification Nameprocessor, cervical cytology slide, automated
Generic Namekit,cervical smear
ApplicantHOLOGIC, INC.
PMA NumberP040052
Date Received12/30/2004
Decision Date03/03/2006
Product Code
MKQ[ Registered Establishments with MKQ ]
Docket Number 06M-0264
Notice Date 06/26/2006
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 
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