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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
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantTRIPATH IMAGING
PMA NumberP970018
Supplement NumberS009
Date Received01/10/2005
Decision Date02/11/2005
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the surepath slide preparation method which will be marketed under the trade name prepstain system and is indicated for use as a liquid-based thin layer cell preparation process. The prestain system produces surepath slides that are intended as replacements for conventional gynecologic pap smears. Surepath slides are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by the bethesda system for reporting cervical/vaginal cytologic diagnoses.
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