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Medtronic VERSAโ„ข Dual Chamber Rate Responsive Pacemaker - HSA Registration DE0506561

Access comprehensive regulatory information for Medtronic VERSAโ„ข Dual Chamber Rate Responsive Pacemaker in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506561 and owned by Medtronic Inc.. The device was registered on January 07, 2022.

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
DE0506561
Medtronic VERSAโ„ข Dual Chamber Rate Responsive Pacemaker
HSA Registration Number: DE0506561
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Product Description

It is indicated for use to improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. It is also indicated for use in patients who are experiencing exercise intolerance or exercise restrictions related to an arrhythmia. Using rate response modes may restore heart rate variability and improve cardiac output. Versa DR Series implantable pulse generators are indicated for single use only.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506561
Registration Date
January 07, 2022
Change Notification Approval Date
April 18, 2024
Retention Due Date
January 06, 2026
Product Owner
Short Name
Medtronic
Address
710 Medtronic Parkway, Minneapolis, MN 55432-5604, 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)
Medtronic VERSAโ„ข Dual Chamber Rate Responsive Pacemaker
Model Identifier(s)
VEDR01