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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHINPREP PROCESSOR (MODEL TP-2000)
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS008
Date Received12/10/2001
Decision Date06/05/2002
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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