Abbott Medical Aveir Leadless Pacing System
- 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
- Risk class
- Class D
- Product owner
- Abbott Medical
- Registrant / registration holder
- ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
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.
- 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
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