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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.
 
DeviceTHINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS010
Date Received02/19/2003
Decision Date03/27/2003
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 FOR THE PRESERVCYT SOLUTION AS AN ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTICS COBAS AMPLICOR CT/NG TEST.
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