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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(R) PROCESSOR
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS003
Date Received09/27/1996
Decision Date04/08/1997
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 THE USE OF POLYETHYLENE TEREPHTHALATE (POLYESTER) AS AN ALTERNATIVE MEMBRANE MATERIAL FOR THE TRANSCYT FILTER FOR GYNECOLOGICAL SPECIMENS AND THEU SE OF THE POLYCARBONATE TRANSCYT FILTERS WITH THE MODIFIED SOFTWARE ON THE THINPREP 2000 SYSTEM
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