Singapore HSA registration DE0019506
BOSTON SCIENTIFIC MOMENTUM™ CRT-D
Singapore·CLASS D·Cardiac Pacemakers Incorporated·Registered August 16, 2017Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0019506
- Registration Date
- August 16, 2017
- Change Notification Approval Date
- May 02, 2024
- Retention Due Date
- August 15, 2025
Product description
These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients who are at risk for sudden cardiac death caused by ventricular arrhythmias and who have heart failure (including asymptomatic [NYHA Class I] ischemic heart failure) with ventricular dyssynchrony.
Product Owner
- Short Name
- Cardiac Pacemakers Incorporated
- Address
- a wholly owned sub of Guidant Corp, a wholly owned sub of, Boston Scientific Corporation, 4100 Hamline Avenue North,, Minnesota 55112-5798, 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)
- MOMENTUM™ CRT-D MOMENTUM™ CRT-D MOMENTUM™ CRT-D MOMENTUM™ X4 CRT-D MOMENTUM™ X4 CRT-D
- Model Identifier(s)
- G124 G125 G126 G128 G138
About this record
Access comprehensive regulatory information for BOSTON SCIENTIFIC MOMENTUM™ CRT-D in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0019506 and owned by Cardiac Pacemakers Incorporated. The device was registered on August 16, 2017.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D