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Medtronic Enertrax Model 7100

FDA 510(k)

Class III (US FDA 510(k))

510(k) K812096

by Medtronic Vascular

Identifiers

510(k) Number
K812096 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 Medtronic Enertrax Model 7100 is an Implantable Pacemaker Pulse-Generator, classified under product code DXY. This device is designed to generate and deliver electrical impulses to regulate the heartbeat in patients with bradycardia or other cardiac conduction disorders, ensuring proper cardiac rhythm and function.

This device is intended for surgical implantation by qualified healthcare professionals in a sterile operating environment. It is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K812096) for traditional review. The device is reusable for single-patient use following sterilization procedures and must comply with MRI safety guidelines as specified by the manufacturer. Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What is the primary clinical purpose of the Medtronic Enertrax Model 7100, and how is it intended to be used in a clinical setting?

The Medtronic Enertrax Model 7100 is an implantable pacemaker pulse-generator designed to regulate heartbeat in patients with bradycardia or cardiac conduction disorders by delivering electrical impulses to maintain proper cardiac rhythm. It is intended for surgical implantation by qualified healthcare professionals in a sterile operating environment, ensuring long-term, internal pacing support for patients who require chronic cardiac rhythm management.

Is the Medtronic Enertrax Model 7100 intended for single-use or reusable applications, and what are the sterilization requirements?

The device is reusable for single-patient use after undergoing sterilization procedures as specified by Medtronic. This means it must be properly cleaned and sterilized between patients to ensure safety and compliance with medical device standards. Sterilization protocols should follow manufacturer guidelines to maintain device integrity and functionality.

What regulatory pathway was followed for FDA clearance of the Medtronic Enertrax Model 7100, and what does this mean for its use in clinical practice?

The Medtronic Enertrax Model 7100 received FDA 510(k) clearance (K812096) under traditional review, with a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means the device was evaluated as comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for implantable pacemaker pulse-generators before being authorized for clinical use in the U.S.

Are there any special handling or storage requirements for the Medtronic Enertrax Model 7100 before and after implantation?

The device must be handled and stored according to standard sterile medical device protocols, as it is intended for surgical implantation. Since it is reusable, it requires proper sterilization between patients to prevent contamination. Additionally, if MRI exposure is anticipated, the device must comply with Medtronic’s MRI safety guidelines to ensure patient safety during imaging procedures.

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: K822147 FDA 510 (k) - MEDTRONIC ENERTRAX MODEL 7100, MEDTRONIC ENERTRAX MODEL 7100 (K822147) — FDA 510(k) | Innolitics, MEDTRONIC ENERTRAX MODEL 7100 (K812096) - FDA 510(k), MEDTRONIC ENERTRAX MODEL 7100 (K812096) - FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K812096 24 fields · synced Oct 6, 2026