Medtronic Attesta™ S DR MRI SureScan™ ATDRS1 Dual Chamber Rate Responsive Pacemaker
- Registration number
- DE0501045
- Model name
- Attesta S DR MRI SureScan; Application Software
- Model identifier
- ATDRS1; SW043
- Registration date
- December 29, 2017
- Source update date
- February 12, 2026
- Risk class
- Class D
- Product owner
- Medtronic Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Pacemakers are intended for long-term use to monitor and regulate the patient’s heart rate. Pacemakers sense intrinsic electrical activity through lead electrodes, analyze heart rhythms based on programmed detection parameters, and deliver pacing pulses to treat bradyarrhythmias. The software is intended to provide information which is used to make decisions with diagnostic or therapeutic devices. The Medtronic ATDRS1 implantable pulse generator (IPG) is indicated for the following conditions: • Accepted patient conditions warranting chronic cardiac pacing • Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increase in activity. It is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony.
- Product owner address
- 710 Medtronic Parkway N.E., Minneapolis MN 55432, USA, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
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.