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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.
 
DeviceTHIN PREP PROCESSORS
Generic NameProcessor, cervical cytology slide, automated
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP950039
Supplement NumberS029
Date Received08/15/2014
Decision Date09/12/2014
Product Code MKQ 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
THE FOLLOWING TEN CHANGES: QUALITY CONTROL (QC) INSTRUCTIONS FOR MICROSCOPE SLIDES INK AND CHIP, ADD A NEW FRICTION FEEDER EQUIPMENT, TP-00372 DOCUMENTATION UPDATE, ELECTRICAL SAFETY TESTING, TRANSFER OF LEGACY (LEGACY PMR) DOCUMENTATION INTO AGILE DOCUMENT CONTROL SYSTEM, INSTRUCTION CLARIFICATION REGARDING AIR VENT HOLES DURING MACHINE ASSEMBLY, MECHANICAL DRIVER BOARDS TESTING, PRESERVCYT QC TESTING, CHANGE IN OWNERSHIP OF LCD BOARD MANUFACTURER, AND IMPROVEMENT TO FIXTURES USED IN THE SCREEN PRINTING PROCESS (SQUEEGEE).
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