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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.
Classification Namereader, cervical cytology slide, automated
Generic Namecervical cytology device
PMA NumberP950009
Supplement NumberS008
Date Received10/04/2007
Decision Date12/03/2008
Product Code
MNM[ Registered Establishments with MNM ]
Docket Number 09M-0016
Notice Date 01/27/2009
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the bd focalpoint gs imaging system. This device is indicated to assist in cervical cancer screening of bd surepath pap test slides to detect evidence of squamous carcinoma, adenocarcinoma, and their usual precursor conditions. These slides will be ranked according to the likelihood of abnormality, and provide relocation and visual review of up to 10 fields of view (fovs) most likely to contain abnormal cells. Additionally, the system identifies at least 15% of all successfully processed slides with the bd focal point slide profiler* directed qc technology for a directed qc re-screen. Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.
Approval Order Approval Order