DevicePMAs@therightstef:P010012_S230 / 572-577 JSONTXT

Approval for a modification to the indications for use for the cognis crt-d models n118, n119; liviancrt-d models h220, h225, h227 and h229; and contak renewal 3 rf he crt-d modelsh210, h215, h217, h219 cardiac resynchronization therapy defibrillators (crt-ds) as follows: these boston scientific cardiac resynchronization therapy defibrillators (crt-ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (opt) for heart failure and who meet any one of the following classifications: 1) moderate to severe heart failure (nyha class iii-iv) with ef <= 35% and qrs duration>= 120 ms; or2) left bundle branch block (lbbb) with qrs >= 130 ms, ef <= 30%, and mild (nyhaclass ii) ischemic or nonischemic heart failure or asymptomatic (nyha class i) ischemic heart failure.

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PMA_MER 1 (1)