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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 PROCESSORS
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS031
Date Received09/30/2014
Decision Date11/20/2014
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REFORMULATION OF TUBING THAT DELIVERS AIR AND PROCESSING REAGENTS TO THE PATIENTS SAMPLE, A CHANGE TO THE PUMP USED ON THE THINPREP® 3000 (TP3000) AND MODIFICATION OF THE T-2000 HEAD LEVER ASSEMBLY TO REDUCE TOLERANCE STACK-UP.
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