Medtronic Attesta™ S DR MRI SureScan™ ATDRS1 Dual Chamber Rate Responsive Pacemaker - HSA Registration DE0501045
Access comprehensive regulatory information for Medtronic Attesta™ S DR MRI SureScan™ ATDRS1 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 DE0501045 and owned by Medtronic Inc.. The device was registered on December 29, 2017.
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.
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.