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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 (MODEL TP-2000)
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS008
Date Received12/10/2001
Decision Date06/05/2002
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the preservcyt solution component of the thinprep 2000 system to be used as an alternative collection and transport medium for gynecologic specimens tested with the roche cobas amplicor ct/ng test.
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