Singapore HSA registration DE0509919
Boston Scientific ACURATE neo2™ Aortic Valve and Transfemoral Delivery System
Singapore·CLASS D·Boston Scientific Corporation·Registered October 16, 2024Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0509919
- Registration Date
- October 16, 2024
- Change Notification Approval Date
- April 29, 2025
- Retention Due Date
- October 15, 2025
Product description
The ACURATE neo2 Aortic Valve, in combination with the ACURATE neo2 Transfemoral Delivery System, is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.
Product Owner
- Short Name
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
- Model Name(s)
- ACURATE neo2™ Loading Kit ACURATE neo2™ Transfemoral Delivery System ACURATE neo2™ Aortic Valve ACURATE neo2™ Aortic Valve ACURATE neo2™ Aortic Valve
- Model Identifier(s)
- SYM-AC-010 SYM-DS-010 SYM-SV23-004 SYM-SV25-004 SYM-SV27-004
About this record
Access comprehensive regulatory information for Boston Scientific ACURATE neo2™ Aortic Valve and Transfemoral Delivery System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509919 and owned by Boston Scientific Corporation. The device was registered on October 16, 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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