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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.
 
DevicePRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM
Generic NameProcessor, cervical cytology slide, automated
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP950039
Supplement NumberS009
Date Received01/21/2003
Decision Date02/05/2003
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 THE FOLLOWING CHANGES TO THE PACKAGE INSERT: 1) THE ADDITION OF A CONTRAINDICATION FOR THOSE SAMPLES PROCESSED USING THE THINPREP 3000 PROCESSING SYSTEM. 2) THE ADDITION OF A PRECAUTION TO ADDRESS THE ALTERNATIVE SPECIMEN PROCESSING METHODS USING THE THINPREP 2000 PROCESSING SYSTEM FOR THOSE SAMPLES THAT WILL BE TESTED FOR CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE USING THE ROCHE DIAGNOSTICS COBAS AMPLICOR CT/NG TEST. 3) THE ADDITION OF THE ALTERNATIVE SPECIMEN HANDLING METHOD TO TABLE 1 OF THE PACKAGE INSERT.
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