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St. Jude Medical Merlin 3650 Programmer

FDA PMA

Class III (US FDA PMA)

PMA P030054

by Abbott Medical

Identity

Trade Name
ST JUDE MEDICAL EPIC HF SYSTEM FDA PMA
Generic Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) FDA PMA

Identifiers

PMA Number
P030054 FDA PMA
FDA Product Code
NIK FDA PMA

Classification

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

The St. Jude Medical Merlin 3650 Programmer is an Automatic Implantable Cardioverter Defibrillator (CRT-D) designed to provide ventricular antitachycardia pacing and defibrillation for automated treatment of life-threatening ventricular arrhythmias. It is intended for use with cardiac resynchronization therapy systems, delivering synchronized electrical impulses to coordinate heart contractions and improve cardiac function in eligible patients.

This device is used in clinical settings to program, monitor, and troubleshoot implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices. Supplied as a reusable medical instrument, it interfaces with FDA-authorized CRT-D systems (e.g., Epic HF and Atlas + HF) and requires proper training for operation. The programmer operates under FDA PMA approval (P030054) and is classified as a Class III device, adhering to strict regulatory standards for cardiac rhythm management technology.

Frequently asked questions

What is the primary purpose of the St. Jude Medical Merlin 3650 Programmer in clinical settings?

The St. Jude Medical Merlin 3650 Programmer is designed to program, monitor, and troubleshoot implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices. It specifically interfaces with FDA-authorized CRT-D systems like the Epic HF and Atlas + HF to deliver synchronized electrical impulses for ventricular antitachycardia pacing and defibrillation, helping automate treatment of life-threatening ventricular arrhythmias and improve cardiac function in eligible patients.

Is the St. Jude Medical Merlin 3650 Programmer a single-use or reusable device, and what does this mean for maintenance?

The St. Jude Medical Merlin 3650 Programmer is explicitly described as a **reusable** medical instrument. This means it is built for repeated use in clinical settings and requires proper cleaning, sterilization, and maintenance protocols to ensure reliability and safety between patient interactions. Reusability also implies it must be handled by trained personnel to avoid contamination or damage.

Which specific cardiac rhythm management systems is the Merlin 3650 Programmer approved to work with, and how does this limit its use?

The Merlin 3650 Programmer is authorized to interface with **FDA-authorized CRT-D systems**, specifically the St. Jude Medical Epic HF and Atlas + HF systems. Its use is therefore limited to programming, monitoring, and troubleshooting these exact systems, ensuring compatibility with their features for ventricular antitachycardia pacing, defibrillation, and cardiac resynchronization therapy. It cannot be used with non-authorized or unrelated cardiac devices.

What regulatory pathway does the St. Jude Medical Merlin 3650 Programmer follow, and why does this matter for buyers?

The Merlin 3650 Programmer follows the **FDA PMA (Premarket Approval) pathway**, holding approval under **PMA number P030054**. This classification as a **Class III device** reflects its critical role in treating life-threatening conditions like ventricular arrhythmias, subjecting it to rigorous pre-market review to ensure safety and effectiveness. Buyers should note this approval is tied to its use with authorized CRT-D systems, ensuring compliance with FDA standards for cardiac rhythm management technology.

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 P030054 24 fields · synced Sep 18, 2026