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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 PROCESSOR 2000/3000
Generic NameProcessor, cervical cytology slide, automated
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP950039
Supplement NumberS021
Date Received02/25/2010
Decision Date03/18/2010
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  
ALTERNATE VENDOR FOR THE MEMBRANE MATERIAL FOR THE MANUFACTURE OF THE THINPREP GYN FILTER USED IN THE THINPREP PROCESSOR 2000 AND THINPREP PROCESSOR 3000.
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