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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.
 
DeviceMONOPREP PAP TEST
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP040052
Supplement NumberS006
Date Received01/18/2008
Decision Date07/09/2008
Withdrawal Date03/21/2017
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
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 LABELING CHANGES BASED ON THE ANALYSIS OF DATA FROM THE POST-MARKET STUDY ENTITLED SURE (SPECIMEN UNSAT RATE EVALUATION). THESE CHANGES HAVE BEEN INCORPORATED INTO THE LABORATORY INFORMATION AND INSTRUCTIONS LABELING.
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