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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 PROCESSOR 2000/3000
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecytology slide preparation device
ApplicantHOLOGIC, INC.
PMA NumberP950039
Supplement NumberS021
Date Received02/25/2010
Decision Date03/18/2010
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate vendor for the membrane material for the manufacture of the thinprep gyn filter used in the thinprep processor 2000 and thinprep processor 3000.
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