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Abbott Medical Aveir Leadless Pacing System - HSA Registration DE0508897

Access comprehensive regulatory information for Abbott Medical Aveir Leadless Pacing System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0508897 and owned by Abbott Medical. The device was registered on January 26, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS COM
DE0508897
Abbott Medical Aveir Leadless Pacing System
HSA Registration Number: DE0508897
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Product Description

The Aveir Leadless Pacemaker System is indicated for patients with bradycardia and: โ€ข Normal sinus rhythm with only rare episodes of A-V block or sinus arrest โ€ข 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.

Device Classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508897
Registration Date
January 26, 2024
Change Notification Approval Date
July 02, 2024
Retention Due Date
January 25, 2026
Product Owner
Short Name
Abbott Medical
Address
Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar CA 91342, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Aveir Delivery Catheter Aveir Retrieval Catheter Aveir Link Module Aveir Introducer Aveir Introducer Aveir Leadless Pacemaker
Model Identifier(s)
LSCD111 LSCR111 LSL02 LSN25301 LSN25501 LSP112V