Recently, China CMDE.NMPA published registration technical review report of Implantable wireless pacemaker.
Product name: Implantable wireless pacemaker
Product category: Class III
Applicant name: Abbott Medical
Product structure and composition:
This product consists of a pulse generator with built-in battery and electrodes and a loading tool.
This product is used in conjunction with programmable controllers, delivery and recovery catheter systems for implantation into the right ventricle to provide pacing therapy for bradycardia. It can sense the heart’s endogenous signals and provide cardiac pacing therapy to the target population. It is suitable for patients with severe bradycardia, normal sinus rhythm with occasional episodes of atrioventricular block or sinus arrest, chronic atrial fibrillation and severe physical disability.
Rate-adaptive pacing is indicated for patients with chronotropic insufficiency and those who would benefit from an increase in pacing rate while performing physical activity.
This product is a medical device that is safe under magnetic resonance environmental conditions. Under specified conditions and on the premise of ensuring that special protective measures are taken for the patient and the implanted equipment, patients can undergo magnetic resonance imaging examinations with clinical 1.5T and 3.0T field strengths.
If you are interested in the original report, please feel free to send email: info@gvmmedical.com