Solvia Rise SR-T - Single-chamber pacemaker, rate-responsive - ARTG 443692
Access comprehensive regulatory information for Solvia Rise SR-T - Single-chamber pacemaker, rate-responsive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 443692 and sponsored by Biotronik Australia Pty Ltd, manufactured by Biotronik SE & Co KG in Germany. The device registration started on March 13, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
Solvia Rise are implantable pacemakers (PM: SR-T and DR-T). A pacemaker is part of an implantable pacemaker system comprising a pacemaker and leads. The primary function of the system is the ability, first, to sense the intrinsic heart rhythm/rate and, second, to provide pacing by electrical pulses of low energy when necessary to ensure a stable heart rate or to support the intrinsic heart rate when needed. The implantation of a pacemaker is a symptomatic therapy with the following objectives: • Sensing and recording the heart rhythm and automatically detecting bradycardia (PMs) • Compensation of bradycardia through atrial or ventricular, or AV sequential pacing (PMs)