Singapore HSA registration DE0506565
Medtronic Advisa™ DR A5DR01 Digital Dual Chamber Pacemaker
Singapore·CLASS D·Medtronic Inc.·Registered January 07, 2022Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0506565
- Registration Date
- January 07, 2022
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- January 06, 2026
Product description
The Advisa DR system is indicated to restore physiologic heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The device is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity.
Product Owner
- Name
- Medtronic Inc.
- 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)
- Application Software Advisa DR
- Model Identifier(s)
- 9995 A5DR01
About this record
Access comprehensive regulatory information for Medtronic Advisa™ DR A5DR01 Digital Dual Chamber 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 DE0506565 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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