Bipolar Optima MP #255 Implantable Pacemaker Pulse-Generator

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

Full name

Bipolar Optima Mp #255

510(k) Number

K813079 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary purpose of the Bipolar Optima MP #255 pacemaker, and who is it designed for?

  The Bipolar Optima MP #255 is an implantable pacemaker pulse-generator designed to regulate heart rhythm by delivering electrical impulses when needed. It is intended for patients with bradycardia or conduction disorders requiring chronic pacing support, helping maintain stable cardiac function through programmable pacing rates and modes.

• Is this device meant for reuse, or is it intended for single-use implantation only?

  The Bipolar Optima MP #255 is explicitly intended for single-use implantation by a qualified physician in a clinical setting. It is supplied sterile and must be handled with sterile technique prior to use, as outlined in the accompanying instructions.

• How should the Bipolar Optima MP #255 be stored, and are there any special handling requirements?

  The device must be stored under specific conditions detailed in the instructions provided by Telectronics, Inc. While the exact storage guidelines aren’t listed here, the device is sterile upon supply and requires sterile handling prior to implantation to prevent contamination. Non-MRI compatibility is also noted, meaning it should not be exposed to MRI environments.

• What regulatory pathway was followed for this device, and which agency approved it?

  The Bipolar Optima MP #255 was cleared through the FDA 510(k) pathway under clearance number K813079, with a decision date of December 10, 1981. It is classified as a Class III medical device under 21 CFR 870.3610 and was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee.

• Can this device be used in patients who require MRI scans, or are there any restrictions?

  No, the Bipolar Optima MP #255 is not MRI-compatible. This means it should never be exposed to MRI environments, as the magnetic fields could interfere with its function or cause harm to the patient. Always verify MRI safety protocols before any imaging procedures.