DevicePMAs@therightstef:P920032_S007 JSONTXT 13 Projects

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."