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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) PROCESSOR
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantCYTYC CORP.
PMA NumberP950039
Supplement NumberS003
Date Received09/27/1996
Decision Date04/08/1997
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of polyethylene terephthalate (polyester) as an alternative membrane material for the transcyt filter for gynecological specimens and theu se of the polycarbonate transcyt filters with the modified software on the thinprep 2000 system.
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