Serena CRT-P MRI SureScan W1TR05 - Biventricular pacemaker

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Medtronic Australasia Pty Ltd

class:

AIMD

manufactured_by:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America

therapeutic_area:

47263 - Biventricular pacemaker

therapeutic_indication:

The Medtronic Serena CRT-P MRI SureScan Model W1TR05 dual chamber implantable pulse generator with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. This device features Bluetooth wireless technology. The Serena CRT-P MRI SureScan system is indicated for any of the following types of heart failure patients: ? Patients with ventricular dyssynchrony ? Patients with reduced ejection fraction (EF), regardless of New York Heart Association (NYHA) class, who are indicated for ventricular pacing, and have high degree AV block ? Patients with reduced EF and all of the following characteristics: ? Have received a conventional pacemaker or an ICD ? Have subsequently developed worsening heart failure despite optimal medical therapy ? Have a high proportion of RV pacing

authorization_status:

A

authorization_date:

2017-07-21