DevicePMAs@therightstef:P010012_S026 / 214-227 JSONTXT

Approval for the contak cd, contak cd 2, renewal, and renewal 3 devices. These devices are indicated for patients with moderate to severe heart failure (nyha iii/iv) who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms.

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PMA_MER 3 (3)