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Description

10.1093/ndt/gfv130 89 KielsteinJ

We note that, while the intended indications for the Aveir TM AR Leadless Pacemaker would appear to match sections of the Breakthrough Device designation, the Breakthrough Device designation provided by the applicant is for the Leadless Dual Chamber System, rather than the Aveir TM Dual-Chamber Leadless Pacemaker