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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHINPREP IMAGING SYSTEM
Classification Namereader, cervical cytology slide, automated
Generic Nameautomated microscope for cytology
ApplicantCYTYC CORP.
PMA NumberP020002
Supplement NumberS002
Date Received03/30/2006
Decision Date04/28/2006
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Hematology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software and labeling modifications of the thinprep imaging system for remote reviewing capability & labeling change for the thinprep imaging system to incorporate a new limitation for specimen reprocessing.
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