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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 LABELING
Classification Namereader, cervical cytology slide, automated
Generic Nameautomated microscope for cytology
ApplicantCYTYC CORP.
PMA NumberP020002
Supplement NumberS005
Date Received08/19/2010
Decision Date09/16/2010
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Hematology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling revisions regarding workload calculation.
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