Device Dossier
Assurity MRI PM1272 - Single-chamber pacemaker, rate-responsive
Device Dossier for Assurity MRI PM1272 - Single-chamber pacemaker, rate-responsive (Single-chamber pacemaker, rate-responsive, Class III, sponsor Abbott…
- GMDN category: Single-chamber pacemaker, rate-responsive
Intended purpose
The Assurity MRI PM1272 is intended to be implanted when a patient has one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of these symptoms. It monitors and regulates a patient's heart rate by providing bradycardia therapy and single-chamber pacing.
Functional description
The Assurity MRI PM1272 is a MRI conditional, single-chamber pulse generator with RF telemetry. This device can be programmed with the Merlin Patient Care System and has device header with IS-1 connector for connection of unipolar or bipolar IS-1 leads. The devices are 1.5 and 3T MR conditional. For MR conditional Device/Lead Combinations refer to manufacturer’s MR conditional Systems Manual.