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Models 5976/5977 Pacemaker Pulse Gener

by Medtronic, Inc.

510(k) K810677

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810677 Date27 May 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DXY
Device class
Class III
Regulation
21 CFR Part 870.3610
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Models 5976/5977 Pacemaker Pulse Generator is an implantable device classified as a pulse-generator for cardiac pacemakers. It is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm.

This device is intended for surgical implantation and is supplied sterile for single-use. It operates within the constraints of Class III regulatory requirements and has received FDA 510(k) clearance under the traditional review pathway. The generator is intended for use in cardiovascular settings and adheres to the regulatory specifications outlined under 870.3610.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Models 5976/5977 Pacemaker Pulse Generator and where is it typically used?

    The Models 5976/5977 Pacemaker Pulse Generator is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm. It is intended for surgical implantation and is specifically used in cardiovascular settings to assist patients with bradycardia or other cardiac rhythm disorders.

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

    This device is supplied sterile and explicitly intended for single-use only. It is not designed or approved for reuse, as it is meant to be implanted surgically and remain in place as a permanent solution for the patient.

  • How was the regulatory clearance for this device obtained, and what pathway was followed?

    The Models 5976/5977 Pacemaker Pulse Generator received FDA 510(k) clearance under the traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. The clearance was granted in 1981, and the device adheres to Class III regulatory requirements for implantable pacemaker pulse-generators.

  • What types of medical specialties are primarily involved with this device?

    This device is categorized under the medical specialty of cardiovascular medicine. It is intended for use by cardiologists, electrophysiologists, and other specialists who manage patients with cardiac rhythm disorders requiring pacemaker therapy.