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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 NumberS015
Date Received04/01/2005
Decision Date09/28/2005
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional claims to the current approved labeling for thinprep 2000 system regarding removal of a 4 ml aliquot from the preservcyt vial prior to preparation of the thinprep pap test(tppt). This aliquot is only to be used to support performance of ancillary tests approved by the fda on preservcyt material.
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