DevicePMAs@therightstef:P060027_S015 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P060027_S015","sourcedb":"DevicePMAs@therightstef","sourceid":"P060027_S015","text":"Approval for the paradym vr model 8250 and dr model 8550 with smartview 2.18ug1 programmer software and the paradym crt-d model 8750 with hardware andmanufacturing changes and labeling and programmer software changes to the ovatio vrmodel 6250, dr model 6550 and crt-d model 6750. the device, as modified, will bemarketed under the trade name paradym vr model 8250 and paradym dr model 8550 withsmartview 2.18ug1 and is indicated for use in patients who are at high risk of sudden cardiacdeath due to ventricular tachyarrhythmias and who have experienced one of the followingsituations: survival of at least one episode of cardiac arrest manifested by the loss ofconsciousness) due to ventricular tachyarrhythmia, recurrent poorly tolerated sustainedventricular 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