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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 NumberS020
Date Received10/01/2009
Decision Date10/02/2009
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of in-house manufacturing for a component of the device to reduce manufacturing time.
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