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Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Oct 8-9)
The committee will discuss, make recommendations, and vote on devices indicated for use in patients with heart failure (HF). On October 8, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the expansion of indications supported by the BLOCK HF trial to apply to all market-approved Medtronic Cardiac Resynchronization Therapy-Pacemaker (CRT-P) and Cardiac Resynchronization Therapy-Defibrillator (CRT-D) devices.
On October 9, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for CardioMEMS, Inc. Champion™ HF Monitoring System. The CardioMEMS HF System is a permanently implantable pressure measurement system designed to provide daily pulmonary arterial pressure measurements including systolic, diastolic, and mean pulmonary arterial (PA) pressure.
For more information on the meeting, visit
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm367579.htm.
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