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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 PROCESSOR 2000/3000 SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantHOLOGIC, INC.
PMA NumberP950039
Supplement NumberS024
Date Received02/14/2012
Decision Date04/09/2012
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the shelf life for thinprep pap test filters.
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