FDA
10th June 2014

Meeting Materials NOW Available! – LUTONIX Catheter

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

Meeting Materials NOW Available! – LUTONIX Catheter

June 12, 2014 8:00 a.m. to 6:00 p.m.: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting 

Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.

Please click HERE for the current roster of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.

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.

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