Singapore HSA registration DE0500635
BOSTON SCIENTIFIC RESONATE™ ICD
Singapore·CLASS D·Cardiac Pacemakers Incorporated·Registered September 13, 2017Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0500635
- Registration Date
- September 13, 2017
- Change Notification Approval Date
- May 02, 2024
- Retention Due Date
- September 12, 2025
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.
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™ EL ICD VR RESONATE™ EL ICD DR RESONATE™ EL ICD VR RESONATE™ EL ICD DR RESONATE™ HF ICD VR RESONATE™ HF ICD DR RESONATE™ HF ICD VR RESONATE™ HF ICD DR
- Model Identifier(s)
- D420 D421 D432 D433 D520 D521 D532 D533
About this record
Access comprehensive regulatory information for BOSTON SCIENTIFIC RESONATE™ 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 DE0500635 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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