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HSA · registration DE0501045

Medtronic Attesta™ S DR MRI SureScan™ ATDRS1 Dual Chamber Rate Responsive Pacemaker

SingaporeCardiovascularClass DMedtronic Inc.
Official record identity
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
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
Published parties
Product owner
Medtronic Inc.
Official description

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.

Additional source fields
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
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.