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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS009
Date Received01/21/2003
Decision Date02/05/2003
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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.