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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 2000 SYSTEM
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS017
Date Received09/05/2006
Decision Date10/05/2006
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
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 REGARDING WARNING AND HANDLING/DISPOSAL INSTRUCTIONS FOR THINPREP 2000 PROCESSORS THAT HAVE BEEN CONTAMINATED WITH TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE).
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