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DevicePMAs@therightstef:P950015_S000 JSONTXT

Approval for The Heart Laser CO2 TMR System. This device is indicated for the treatment of patients with stable angina (Canadian Cardiovascular Society class 3 or 4) refractory to medical treatment and secondary to objectively demonstarted coronary artery atherosclerosis not amenable to direct coronary revascularization.

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