国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
ELLIXION HEALTHCARE PTE LTD
Class D medical device
Impulse Dynamics (USA), Inc.
Cardiovascular
It is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction despite appropriate medical therapy. The OPTIMIZER Smart systems delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.
Device System Info:[Sterile Medical Device], Sterilized by ethylene oxide.; Models: OPTIMIZER Smart Implantable Pulse GeneratorFor the Treatment of Heart Failure - 10-B411-3-SG, Mini Charger/Wand - 13-100-002, Optimizer Mini Charger System - 10-F202-3-SG, OMNI II Programmer System with OMNI Smart Software (OMNI II Application Enabled) - 10-A604-3-SG
2020-08-04