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Microny Pacemakers

FDA PMA

Class III (US FDA PMA)

PMA P970013

by Abbott Medical

Identity

Trade Name
MICRONY PACEMAKERS FDA PMA
Generic Name
Pulse-generator, single chamber, sensor driven, implantable FDA PMA

Identifiers

PMA Number
P970013 FDA PMA
FDA Product Code
LWO FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Microny Pacemakers Model 2425T is a pulse-generator, single chamber, sensor-driven, implantable device designed for chronic cardiac pacing. It is programmed with compatible programmers, including the APS II with Model 3204A software, the APSU programmer, and the Model 3500/3510 with Model 3304 software. This device is intended for patients with conditions such as sick sinus syndrome, chronic AV block, recurrent Adams-Stokes syndrome, and symptomatic bundle branch block, as well as for rate-modulated pacing during physical activity.

The Model 2425T is implanted subcutaneously and is intended for single-chamber pacing applications, including atrial and ventricular pacing. It is supplied sterile and intended for single-use implantation. The device is classified as Class III under FDA regulations and holds a PMA approval (P970013). Compatible models include FEI numbers 2017865, 3006705815, 3013288201, 3008377825, and 3000203466, with storage and handling adhering to standard implantable cardiac device protocols.

Frequently asked questions

What types of patients is the Microny Pacemaker Model 2425T intended for, and how does it address their conditions?

The Microny Pacemaker Model 2425T is designed for patients with chronic cardiac pacing needs, including those with sick sinus syndrome, chronic AV block, recurrent Adams-Stokes syndrome, and symptomatic bundle branch block. It also supports atrial pacing for sinus node dysfunction with normal conduction systems and ventricular pacing for bradycardia due to conditions like atrial fibrillation or severe physical disability. The device’s sensor-driven feature enables rate-modulated pacing, adjusting pacing rates during physical activity to better match the patient’s needs.

How is the Microny Pacemaker Model 2425T programmed, and which compatible programmers are available?

The Microny Pacemaker Model 2425T is programmed using specific external devices designed for compatibility. Authorized programmers include the APS II with Model 3204A software, the APSU programmer, and the Model 3500/3510 with Model 3304 software. These tools allow clinicians to configure pacing parameters tailored to the patient’s clinical condition.

Is the Microny Pacemaker Model 2425T intended for single-use or reusable implantation, and how should it be handled?

The Microny Pacemaker Model 2425T is supplied sterile and intended for **single-use implantation only**. As an implantable device, it must be handled according to standard sterile protocols for cardiac devices to prevent contamination before and during surgery. Follow manufacturer guidelines for storage and preparation to ensure device integrity.

What regulatory pathway was followed for the approval of the Microny Pacemaker Model 2425T, and what does this mean for its use?

The Microny Pacemaker Model 2425T received **FDA PMA approval (P970013)**, which is the regulatory pathway for high-risk medical devices like Class III cardiac pacemakers. This approval confirms that the device meets stringent safety and effectiveness standards for its intended use in chronic cardiac pacing, including sensor-driven rate modulation. Clinicians and buyers can rely on this approval as evidence of its compliance with U.S. regulatory requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA PMA P970013 24 fields · synced Sep 18, 2026