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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.
Classification Nameprocessor, cervical cytology slide, automated
Generic Nameprocessor, cervical cytology slide, automated
250 campus drive
marlborough, MA 01752
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008