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BOSTON SCIENTIFIC RESONATE™ CRT-D - HSA Registration DE0019508

Access comprehensive regulatory information for BOSTON SCIENTIFIC RESONATE™ 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 DE0019508 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.

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CLASS D
DE0019508
BOSTON SCIENTIFIC RESONATE™ CRT-D
HSA Registration Number: DE0019508
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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.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0019508
Registration Date
August 16, 2017
Change Notification Approval Date
March 13, 2025
Retention Due Date
August 15, 2025
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)
RESONATE™ CRT-D RESONATE™ CRT-D RESONATE™ CRT-D RESONATE™ X4 CRT-D RESONATE™ X4 CRT-D RESONATE™ X4 CRT-D RESONATE™ X4 CRT-D RESONATE™ HF CRT-D RESONATE™ HF CRT-D RESONATE™ HF CRT-D RESONATE™ HF CRT-D RESONATE™ HF CRT-D RESONATE™ HF CRT-D RESONATE™ HF CRT-D
Model Identifier(s)
G424 G425 G426 G428 G437 G447 G448 G524 G525 G526 G528 G537 G547 G548