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HSA · registration DE0508897

Abbott Medical Aveir Leadless Pacing System

SingaporeCardiovascularClass DAbbott Medical
Official record identity
Registration number
DE0508897
Model name
Aveir Delivery Catheter; Aveir Delivery Catheter; Aveir Retrieval Catheter; Aveir Link Module; Aveir Introducer; Aveir Introducer; Aveir Leadless Pacemaker; Aveir Leadless Pacemaker; Aveir Leadless Pacemaker
Model identifier
LSCD111; LSCD201; LSCR111; LSL02; LSN25301; LSN25501; LSP112V; LSP201A; LSP202V
Registration date
January 26, 2024
Source update date
October 08, 2025
Classification
Risk class
Class D
Official value: D WITH MEDICINAL PRODUCT
Published category
Cardiovascular
Published parties
Product owner
Abbott Medical
Registrant / registration holder
ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
Official description

The Aveir Leadless Pacemaker system is indicated for management of one or more of the following chronic clinical presentations: ▪ Syncope ▪ Pre syncope ▪ Fatigue ▪ Disorientation Dual chamber pacing is indicated for patients exhibiting one or more of the following conditions: ▪ Sick sinus syndrome ▪ Chronic, symptomatic second and third degree AV block ▪ Recurrent Adams Stokes syndrome ▪ Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out Atrial pacing is indicated for patients with: ▪ Sinus node dysfunction and normal AV and intraventricular conduction systems Ventricular pacing is indicated for patients with significant bradycardia and: ▪ Normal sinus rhythm with only rare episodes of AV block or sinus arrest or ▪ Chronic atrial fibrillation Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.

Additional source fields
Product owner address
Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar CA 91342, United States
Registrant address
3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.