Singapore HSA registration DE0013354
Medtronic SELECTSECURE™ 3830 lead
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 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.
Product Owner
- Name
- Medtronic Inc
- 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
About this record
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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