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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 NamePREPSTAIN SYSTEM/PREPMATE
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantTRIPATH IMAGING, INC.
PMA NumberP970018
Supplement NumberS024
Date Received08/24/2011
Decision Date09/21/2011
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the product labeling and the prepmate operator manual. Requested changes to the product labeling include updating the met mark, updating the manufacturing address and ec authorized representative name and address, adding ce mark, and adding bd branding to serial number labels and box labels. Changes to the operator manual include editorial changes intended to clarify and/or correct some existing text, which included updating the company and instrument name and branding.
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