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Implantable Program-Cardiac Pulse Gen-Optima Mp II

by Telectronics, Inc.

510(k) K851081

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 NumberK851081 Date4 Apr 1985ClearedStatusActive

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  • Withdrawn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 Implantable Program-Cardiac Pulse Generator Optima MP II is a Class III implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients requiring temporary or permanent pacing support to manage bradycardia or other cardiac conduction disorders.

This device is supplied as a reusable, implantable component and is regulated under FDA 510(k) clearance (K851081) with a decision classification of Substantially Equivalent. It is intended for use in clinical settings by trained medical professionals and must be implanted via sterile surgical procedures. The device adheres to regulatory standards outlined in 21 CFR 870.3610 and is categorized under product code DXY.

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