HSA · registration DE0506565Medtronic Advisa™ DR A5DR01 Digital Dual Chamber Pacemaker
SingaporeCardiovascularClass DMedtronic Inc.
Official record identity
- Registration number
- DE0506565
- Model name
- Application Software; Advisa DR
- Model identifier
- 9995; A5DR01
- Registration date
- January 07, 2022
- Source update date
- April 22, 2022
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Medtronic Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Official 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.
Additional source fields
- Product owner address
- 710 Medtronic Parkway, Minneapolis, MN 55432-5604, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.