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Medtronic SELECTSECURE™ 3830 lead - HSA Registration DE0013354

Access comprehensive regulatory information for Medtronic SELECTSECURE™ 3830 lead in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0013354 and owned by Medtronic Inc. The device was registered on July 10, 2013.

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 COM
DE0013354
Medtronic SELECTSECURE™ 3830 lead
HSA Registration Number: DE0013354
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Product Description

The SelectSecure™ 3830 Lead has application where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated. The Model 3830 lead is intended for pacing and sensing in the atrium or ventricle. The SelectSecure™ MRI SureScan™ 3830 Lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system.

Device Classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0013354
Registration Date
July 10, 2013
Change Notification Approval Date
November 04, 2024
Retention Due Date
July 09, 2025
Product Owner
Short Name
Medtronic Inc
Address
8200 Coral Sea Street, MS MV S11, Mounds View, MN 55112, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
SelectSecure™ MRI SureScan™ 3830 Lead SelectSecure™ MRI SureScan™ 3830 Lead SelectSecure™ 3830 Lead SelectSecure™ 3830 Lead SelectSecure™ 3830 Lead SelectSecure™ 3830 Lead SelectSecure™ MRI SureScan™ 3830 Lead SelectSecure™ 3830 Lead SelectSecure™ 3830 Lead
Model Identifier(s)
383059   383074   3830110   383059   383074   383098    383069   383049   383069