ARTG 443693Solvia Rise DR-T - Dual-chamber pacemaker, rate-responsive
ARTG ID: 443693 · Biotronik Australia Pty Ltd · Biotronik SE & Co KG · Class III · Started March 13, 2024
Good Name: Biotronik Australia Pty Ltd - Solvia Rise DR-T - Dual-chamber pacemaker, rate-responsive
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 443693
- Start Date
- March 13, 2024
- Effective Date
- March 13, 2024
- Country
- Germany
- Address
- Woermannkehre 1, Berlin, D-12359
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)
Access comprehensive regulatory information for Solvia Rise DR-T - Dual-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 443693 and sponsored by Biotronik Australia Pty Ltd, manufactured by Biotronik SE & Co KG in Germany. The device registration started on March 13, 2024.
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