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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 NameTHINPREP (R) IMAGING SYSTEM
Classification Namereader, cervical cytology slide, automated
Generic Nameautomated microscope for cytology
ApplicantCYTYC CORP.
PMA NumberP020002
Date Received01/07/2002
Decision Date06/06/2003
Product Code
MNM[ Registered Establishments with MNM ]
Docket Number 03M-0339
Notice Date 07/30/2003
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 thinprep imaging system. The device is indicated for assisting in primary cervical cancer screening of thinprep pap test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (low grade squamous intraepithelial lesions, high grade squamous intraepithelial lesions, and carcinoma as well as all other cytological criteria as defined by the 2001 bethesda system: terminology for reporting results of cervical cytology.
Approval Order Approval Order
Supplements: S001 S002 S003 S005 S006 S007 S008 
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