During this meeting, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC.
October 1, 2014 8:00 a.m. to 6:00 p.m.: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Hilton Washington DC/North
Salons A, B, C, and D
620 Perry Pkwy.
Gaithersburg, MD 20877
During this meeting, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for the SONABLATE 450 device is for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.Please click HERE for the current roster of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee.
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