Following are comments from some FDA panelists who reviewed the
application:
John Baxley, Principal FDA Reviewer:
“The decision to grant expedited review status to this
application
was based on our belief that the Prostatron represented a breakthrough
device for the treatment of BPH….”
Saul Boyarsky, Clinical Professor of Urology, St. Louis
University:
“…the company and the agency deserve a lot of credit.
This has been
a much improved procedure. This is a big step forward, and I would
again applaud the company for having had the fortituted to stick
wit thermal
energy, as a new historic jump.”
Milorad Jevitch, FDA Medical Officer
“I have reviewed this PMA (premarket approval) with great
interest and pleasure.
The study and the PMA document are an excellent example of a well-designed,
well-
conducted and well-run study. The sponsor and the many investigators
should be given credit for an excellent job done.”
A USRF website posting on the Prostatron appeared in 1998
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