Aveir VR Leadless System

FDA premarket approval P150035 · Leadless pacemaker

PMA numberP150035

Approval

Applicant
Abbott Medical
Received
October 6, 2015
Decision date
March 31, 2022 (APPR)
Supplements
41, latest August 27, 2026
Product code
PNJ – Leadless Pacemaker

Official FDA PMA record

Approval order statement

Approval for the Aveir Leadless Pacemaker, Aveir Delivery System Catheter, and Aveir Link Module.