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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 SLIDES
Generic NameProcessor, cervical cytology slide, automated
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP950039
Supplement NumberS027
Date Received12/31/2013
Decision Date01/29/2014
Product Code MKQ 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
ADDITION OF A SPECIFICATION ON MINIMUM CELL TRANSFER REQUIREMENTS FOR THE THINPREP MICROSCOPE SLIDES.
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