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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 2000 SYSTEM
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS015
Date Received04/01/2005
Decision Date09/28/2005
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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