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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 NumberS016
Date Received07/22/2005
Decision Date01/18/2006
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL CLAIMS TO THE CURRENT LABELING. THE ADDITIONAL CLAIMS CONSIST OF EXTENSION OF THE EXPIRATION DATE OF THE PRESERVCYT SAMPLE VIALS TO SIX WEEKS, REPROCESSING "UNSATISFACTORY FOR EVALUATION" SLIDES WITH A CYTOLYT SOLUTION AND GLACIAL ACETIC ACID WASH, AND REFERENCE TO THE GEN-PROBE APTIMA ASSAYS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE.
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