June 12, 2014 8:00 a.m. to 6:00 p.m.: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement.
June 12, 2014 8:00 a.m. to 6:00 p.m.: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Holiday Inn Express/Highlands Conference Center
20260 Goldenrod Lane
Germantown, MD 20876
During this meeting, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the LUTONIX 035 Drug Coated Balloon PTA Catheter sponsored by Lutonix, Inc. The LUTONIX 035 Drug Coated Balloon PTA Catheter (LUTONIX DCB) is an over-the-wire percutaneous transluminal
The proposed indications for use are for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤15cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm. angioplasty (PTA) catheter with a paclitaxel-based drug coating on the surface of the balloon. The LUTONIX DCB is compatible with a 0.035” guidewire and has balloon sizes ranging from 4 millimeters (mm) to 6 mm in diameter and 40 mm to 100 mm in length. The LUTONIX DCB catheter is available in 75 centimeters (cm), 100 cm and 130 cm working lengths.
Please click HERE for the current roster of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.
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