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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 NameTHINPREP(R) 2000 SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS002
Date Received07/30/1996
Decision Date02/25/1997
Product Code
MKQ[ Registered Establishments with MKQ ]
Docket Number N
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the combination of endocervical brush and plastic spatula as an alternative tot he broom-type sampling device for the thinprep 2000 system.
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