|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170|
|Classification Name||generator, pulse, pacemaker, external programmable|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
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. ".