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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.
 
Trade NameTHINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS010
Date Received02/19/2003
Decision Date03/27/2003
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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