FDA
16th June 2014

Meeting Announcement – Ablatherm Integrated Imaging device

During the first session on July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc.

Meeting Announcement – Ablatherm Integrated Imaging device

July 30-31, 2014 8:00 a.m. to 6:00 p.m.: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Where:

Hilton Washington DC North/Gaithersburg
Salons A, B, C, and D
620 Perry Pkwy Gaithersburg, MD 20877
301-977-8900

During the first session on July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The

The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows:

During the second session on July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, “Monitor, Penile Tumescence,” Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, “Catheter, Nephrostomy,” Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, “Stimulator, Electrical for Sperm Collection,” Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, “Device, Erectile Dysfunction,” Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, “Spermatocele, Alloplastic,” Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

Please click HERE for the current roster of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee.

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