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Pulse Generator, A-V Seq.

FDA 510(k)

Class III (US FDA 510(k))

510(k) K772202

by Medtronic Vascular

Identifiers

510(k) Number
K772202 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)

This device is an Implantable Pacemaker Pulse-Generator (product code DXY), designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It functions as part of a pacemaker system, providing synchronized atrioventricular (A-V) pacing to maintain proper heart function in patients with conduction disorders.

The Pulse Generator, A-V Seq. is intended for implantable use and has received FDA 510(k) clearance under the Substantially Equivalent (SESE) determination. Classified as a Class III device under regulation 870.3610, it is regulated for cardiovascular applications and supplied as a reusable component within a sterile packaging system for surgical implantation. Authorized under K772202, it adheres to premarket approval requirements for implantable cardiac devices.

Frequently asked questions

What is the primary purpose of the Pulse Generator, A-V Seq., and how does it function within a patient’s body?

The Pulse Generator, A-V Seq. is designed to regulate cardiac rhythm by delivering synchronized atrioventricular (A-V) pacing. It works as part of an implantable pacemaker system, providing electrical impulses to the heart to maintain proper timing between atrial and ventricular contractions, which is critical for patients with conduction disorders.

Is this device intended for single-use or can it be reused after implantation?

The Pulse Generator, A-V Seq. is supplied as a reusable component within a sterile packaging system specifically for surgical implantation. While the device itself is intended for long-term use within the patient, the sterile packaging ensures it remains uncontaminated during the implantation procedure.

What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

This device received FDA 510(k) clearance under the Substantially Equivalent (SESE) determination, classified as a Class III device under regulation 870.3610. The classification reflects its role in cardiovascular applications, requiring premarket approval due to its implantable nature and potential risks.

How is the device packaged for surgical use, and what considerations should be made during storage?

The Pulse Generator, A-V Seq. is supplied in sterile packaging designed for surgical implantation. Since it is reusable within the patient but must remain sterile during handling, proper storage conditions—such as protecting it from contamination, extreme temperatures, or physical damage—are essential to maintain its integrity before and after use.

Are there multiple models or sizes available for this device, and how would a clinician determine the appropriate one for a patient?

The provided data does not specify distinct models or sizes for the Pulse Generator, A-V Seq., but it is classified as an Implantable Pacemaker Pulse-Generator (product code DXY) for A-V sequencing. Selection would depend on clinical assessment, patient-specific conduction disorders, and compatibility with the implanted leads or pacing system, typically determined in consultation with a cardiologist or electrophysiologist.

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: PULSE GENERATOR, A-V SEQ. (K772202) - FDA 510 (k), PULSE GENERATOR, A-V SEQ. (K772202) — FDA 510(k) | Innolitics, Pulse Generator, A-v Seq. 510 (k) K772202 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K772202 24 fields · synced Oct 6, 2026