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BOSTON SCIENTIFIC CHARISMA™ EL ICD - HSA Registration DE0500637

Access comprehensive regulatory information for BOSTON SCIENTIFIC CHARISMA™ EL ICD in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0500637 and owned by Cardiac Pacemakers Incorporated. The device was registered on September 13, 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
DE0500637
BOSTON SCIENTIFIC CHARISMA™ EL ICD
HSA Registration Number: DE0500637
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Product Description

Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0500637
Registration Date
September 13, 2017
Change Notification Approval Date
January 25, 2024
Retention Due Date
September 12, 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)
CHARISMA™ EL ICD VR CHARISMA™ EL ICD DR CHARISMA™ EL ICD VR CHARISMA™ EL ICD DR
Model Identifier(s)
D320 D321 D332 D333