Singapore HSA registration DE0508897
Abbott Medical Aveir Leadless Pacing System
Singapore·CLASS COM·Abbott Medical·Registered January 26, 2024Device 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 description
The Aveir Leadless Pacemaker System is indicated for patients with bradycardia and: • Normal sinus rhythm with only rare episodes of A-V block or sinus arrest • 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
- Name
- Abbott Medical
- 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
About this record
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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