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Minix 8341M and Minix ST 8331M Pulse Generators

FDA 510(k)

Class III (US FDA 510(k))

510(k) K894055

by Medtronic Vascular

Identifiers

510(k) Number
K894055 FDA 510(k)
FDA Product Code
DXY FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3610 FDA 510(k)
Regulation Number
870.3610 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Minix 8341M and Minix ST 8331M Pulse Generators are implantable pacemaker pulse-generators, classified under product code DXY. These devices provide electrical stimulation to regulate heart rhythm by delivering timed pulses to the heart chambers, ensuring proper cardiac function in patients with bradycardia or conduction disorders.

These pulse generators are intended for implantation and are designed for single-use within the body. They are regulated under FDA 510(k) clearance (K894055) and fall under Class III medical device requirements. Supplied sterile, they require professional medical implantation and are not compatible for MRI use. Authorized by Medtronic Vascular, they adhere to regulatory standards for cardiovascular devices.

Frequently asked questions

Are these pulse generators designed for reuse or are they intended for single-use only within the body?

The Minix 8341M and Minix ST 8331M Pulse Generators are explicitly designed for single-use within the body after implantation. This is a key design feature to ensure patient safety and reliability, as they are intended to remain implanted long-term to regulate heart rhythm.

How are these devices supplied, and do they require any special handling before implantation?

These pulse generators are supplied sterile and are intended for professional medical implantation. Since they are implantable devices, they must be handled in a sterile environment to prevent infection, and only trained clinicians should perform the procedure.

Are there different sizes or models available for these pulse generators, and how would a clinician determine the right fit for a patient?

The data provided does not specify distinct sizes or models beyond the two listed (8341M and ST 8331M). However, as implantable pacemaker pulse generators, selection typically depends on clinical assessment, patient anatomy, and specific pacing requirements. A clinician would consult manufacturer guidelines and patient-specific factors to determine compatibility.

Can these devices be used in patients who require MRI scans, or are they MRI-compatible?

The Minix 8341M and Minix ST 8331M Pulse Generators are not compatible with MRI use. This is explicitly stated in the device description, meaning they should not be implanted in patients who may need MRI imaging in the future, as MRI can interfere with or damage implantable cardiac devices.

What regulatory pathway was followed for these pulse generators, and which advisory committee was involved?

These devices were cleared through the FDA’s 510(k) pathway under the traditional review process, with a decision of Substantially Equivalent (SESE). The Cardiovascular (CV) Advisory Committee was involved in the review process, as indicated by the product code (DXY) and regulatory filings.

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. Sources consulted: K894055 FDA 510(k) - MINIX 8341M AND MINIX ST 8331M PULSE GE..., Minix 8341m and Minix St 8331m Pulse Generators, PDF K894055 - Minix 8341m and Minix St 8331m Pulse Generators, Minix 834m & Minix St 8331m Pulse Generators (Modification) (K953866 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K894055 24 fields · synced Sep 18, 2026