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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 NumberS004
Date Received07/27/2007
Decision Date08/31/2007
Withdrawal Date03/21/2017
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 USE OF REFLECTIVE WHITE LABEL STOCK (PN 12358) ON ALL MONOPREP VIALS, INCLUDING THE MONOPREP PAP TEST VIAL AND THE REPROCESSING VIAL.
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