Singapore HSA registration DE0509900
Abbott Medical Amplatzer Muscular VSD Occluder
Singapore·CLASS D·Abbott Medical·Registered October 11, 2024Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0509900
- Registration Date
- October 11, 2024
- Retention Due Date
- October 10, 2025
Product description
The Amplatzer Muscular VSD Occluder are percutaneous, transcatheter, ventricular septal defect closure devices designed for the occlusion of muscular ventricular septal defects. Inclusion Criteria • Patients with demonstrated muscular ventricular septal defects either by echocardiography or left ventriculography. • A distance of 3 mm of the muscular communication to the ventricular apex. • Body weight >8 kgs. • Ventricular communications with or without pulmonary hypertension and acyanosis. • Patients who underwent surgical closure of ventricular septal defects and have a residual left to-right shunt. • Patients with previous myocardial infarctions and ventricular septal defect.
Product Owner
- Name
- Abbott Medical
- Short Name
- Abbott Medical
- Address
- 5050 Nathan Lane North, Plymouth, MN 55442, 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)
- Amplatzer Muscular VSD Occluder Amplatzer Muscular VSD Occluder Amplatzer Muscular VSD Occluder Amplatzer Muscular VSD Occluder Amplatzer Muscular VSD Occluder Amplatzer Muscular VSD Occluder Amplatzer Muscular VSD Occluder Amplatzer Muscular VSD Occluder
- Model Identifier(s)
- 9-VSD-MUSC-004 9-VSD-MUSC-006 9-VSD-MUSC-008 9-VSD-MUSC-010 9-VSD-MUSC-012 9-VSD-MUSC-014 9-VSD-MUSC-018 9-VSD-MUSD-016
About this record
Access comprehensive regulatory information for Abbott Medical Amplatzer Muscular VSD Occluder in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509900 and owned by Abbott Medical. The device was registered on October 11, 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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