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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 NameBD PREPSTAIN SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantTRIPATH IMAGING, INC.
PMA NumberP970018
Supplement NumberS025
Date Received05/18/2012
Decision Date11/08/2012
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a supplier change to the raw microsope slide, a critical component in the device.
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