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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 2000 SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS017
Date Received09/05/2006
Decision Date10/05/2006
Product Code
MKQ[ Registered Establishments with MKQ ]
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 changes regarding warning and handling/disposal instructions for thinprep 2000 processors that have been contaminated with transmissible spongiform encephalopathy (tse).
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