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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 (TM) SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantTRIPATH IMAGING
PMA NumberP970018
Supplement NumberS006
Date Received03/24/2003
Decision Date05/02/2003
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the current approved labeling to include data and information from a direct-to-vial clinical study for high grade squamous intraepithelial and more severe lesions.
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