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Singapore HSA registration DE0502237

Boston Scientific EMBLEM™ S-ICD Electrode Delivery System

Singapore flagSingapore·CLASS B·Cardiac Pacemakers Incorporated·Registered October 04, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0502237
Registration Date
October 04, 2018
Change Notification Approval Date
January 16, 2024
Retention Due Date
October 03, 2025
Product description
The EMBLEM S-ICD Electrode Delivery System (the "EDS") is a component of the Boston Scientific S-ICD System, which is prescribed for patients when cardiac arrhythmia management is warranted. The EDS consists of two tunneling tools with pre-loaded introducer sheaths and is used to create subcutaneous tunnels to facilitate implantation of the EMBLEM S-ICD Subcutaneous Electrode.
Product Owner
Name
Cardiac Pacemakers Incorporated
Short Name
Cardiac Pacemakers Incorporated
Address
A wholly owned sub of Guidant Corp., A wholly owned sub of Boston, Scientific Corp., 4100 Hamline Avenue North, Minnesota 55112, UNITED STATES
Registrant
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
Model Name(s)
EMBLEM™ S-ICD Electrode Delivery System
Model Identifier(s)
4712
About this record

Access comprehensive regulatory information for Boston Scientific EMBLEM™ S-ICD Electrode Delivery System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502237 and owned by Cardiac Pacemakers Incorporated. The device was registered on October 04, 2018.

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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