FDAAdvisoryCommittee.com
March 18 & 19, 2010 - Circulatory System Devices Panel of the Medical Devices Advisory Committee Committee
PMA - CRT-Ds (Boston Scientific)
PMA - REVO MRI Pacemaker System (Medtronic)
Agenda: On March 18, 2010, the committee will discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) sponsored by Boston Scientific. The sponsor is seeking expanded indications for the their CRT-Ds to include patients with low left ventricular ejection fraction (<=30%) and wide QRS (>=130 ms) who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology).
Agenda: On March 19, 2010, the committee will discuss, make recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions.
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