DevicePMAs@therightstef:P920032_S007 / 515-520 JSONTXT

Approval for the model 4170 bedside single chamber, external pulse generator. The model 4170 is indicated for "any clinical situation in which the use of temporary pacemaker on a patient provides therapeutic or diagnostic value, or serves a prophylactic purpose. Specifically, indications for temporary pacemakers include, but are not limited to, the following: intermittent or complete heart block associated with asystole or bradycardia, symptomatic sinus bradycardia, surgically-induced heart block and heart block accompanying an acute myocardial infarction."

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PMA_MER 1 (1)