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ProUroCare Medical Announces Filing of Request to Classify the Prostate Mechanical Imager ("PMI") as a Class II Device
Date:5/24/2010

MINNEAPOLIS, May 24 /PRNewswire-FirstCall/ -- ProUroCare Medical, Inc. (OTC Bulletin Board: PUMD, PUMDU and PUMDW), a provider of proprietary imaging products, today announced that a meeting was held with the FDA on May 19th to review the 510(k) application for the Prostate Mechanical Imaging (PMI) system, also known as the ProUroScan™ system, and to discuss the requirements for filing a reclassification request (a de novo filing) in accordance with Section 513(f)(2) of the Federal Food, Drug and Cosmetic Act.  On May 21st, a de novo application was filed with the FDA for the ProUroScan (PMI) system.

Following the filing of the initial 510(k) application for the PMI system, the FDA issued a letter stating that the PMI system was not "substantially equivalent" to currently marketed devices.  As required by the Section 513(f)(2) guidance document, a submission was made on May 19th to request 510(k) clearance under the de novo process.  This request asked the FDA to define mechanical imaging systems as devices that are intended to produce an elasticity image of the prostate as an aid in documenting abnormalities of the prostate that are initially identified by digital rectal examination and to be used by physicians as a documentation tool.  

The de novo submission also recommended that the classification regulation state that a "mechanical imaging system" device consists of a trans-rectal probe with pressure sensor arrays and a motion tracking system that provides real time images of the prostate.  These proprietary components are unique to the ProUroScan system.  

The primary benefit of a de novo filing is that it will allow the agency to review and potentially classify m
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SOURCE ProUroCare Medical, Inc.
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