4635fda4-ec3b-4519-bf55-925834aa2c5fUpdatePublished22018-03-292014-09-24In Commercial Distribution00852184003311PrimaryGS1System Destination Kit, 2-EPG, Canada20-0065138432070Synapse Biomedical, Inc.1falsefalsefalsetruefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse47808Intramuscular diaphragm/phrenic nerve electrical stimulation systemAn assembly of battery-powered devices designed to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve to contract the diaphragm rhythmically and cause the patient to draw breath in a manner similar to natural breathing. It typically consists of implanted intramuscular electrodes placed in the diaphragm in proximity to the phrenic nerve motor point, an external pulse generator (EPG), and a cable to connect the externally exposed ends of the electrodes with the EPG. The system typically controls parameters such as pulse amplitude, pulse duration, pulse frequency, inspiration time, and respiratory rate.trueActiveOIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulatorfalsefalse