Medtronic Micra™ AV2 Dual Chamber Transcatheter Pacing System - HSA Registration DE0510093
Access comprehensive regulatory information for Medtronic Micra™ AV2 Dual Chamber Transcatheter Pacing System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0510093 and owned by Medtronic, Inc. The device was registered on November 29, 2024.
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Indicated for VDD pacing in patients when a dual chamber transvenous pacing system is considered a poor option or not deemed necessary for effective therapy, and when a right ventricular transcatheter pacing system promoting AV synchrony at rest is acceptable. Conditions when a patient is considered a poor candidate for transvenous pacing may include, but are not limited to, tortuous anatomy, a need to preserve venous access, or increased risk of infection. The device provides AV synchrony at rest and rate responsive (VVIR) pacing during periods of high patient activity. Indicated for use in patients who have experienced one of the following: Paroxysmal or permanent high-grade AV block in the absence of AF, in the presence of paroxysmal AF, in the presence of persistent AF when attempts at restoring sinus rhythm are still planned. The device is designed to be used only in the right ventricle.