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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 NumberS003
Date Received10/26/2001
Decision Date11/02/2001
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for name changes from autocyte prep system to prepstain system and from cytorich to surepath. The device, as modified, will be marketed under the trade names prepstain system and surepath. The prepstain system and surepath is indicated as a liquid-based, thin layer cell preparation process. The prepstain system produces slides that are intended as replacements for conventional gynecologic pap smears. The prepstain slides are intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by the bethesda system for reporting cervical/vaginal cytologic diagnoses.
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