Optima Series II Model 147B Single Chamber Pulse

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

510(k) Number

K903186 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Telectronics Pacing Systems, Inc. →

• What types of patients is the Optima Series II Model 147B Single Chamber Pulse designed to support, and how does it work?

  This device is designed for patients with bradycardia or conduction system disorders, where the heart’s natural pacemaker fails to maintain a regular heartbeat. It delivers timed electrical impulses to either the atrium or ventricle, stimulating the heart muscle to contract at a consistent rate. This ensures proper cardiac rhythm when the patient’s natural pacemaker is insufficient.

• Is the Optima Series II Model 147B Single Chamber Pulse intended for reuse, or is it meant to be implanted once and discarded?

  The device is explicitly labeled as non-reusable. It is supplied sterile for surgical implantation and is intended to remain implanted in the patient indefinitely, providing continuous pacing support. Reuse is not permitted or recommended.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The Optima Series II Model 147B underwent a traditional review pathway through the FDA’s Cardiovascular Advisory Committee, with a decision of ‘Substantially Equivalent’ (SESE). This means the device was compared to a legally marketed predicate and determined to have the same intended use, technological characteristics, and safety and effectiveness factors. Clinicians can rely on this clearance as evidence of the device’s regulatory scrutiny and compliance with FDA standards.

• How is the device supplied, and what considerations should be made during storage or handling before implantation?

  The device is supplied sterile, ready for surgical implantation. Since it is non-reusable, proper sterile handling is critical before use. Storage should follow manufacturer guidelines to maintain sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always verify the packaging integrity and expiration date before opening.

• Does this device require any specific professional qualifications for implantation, and why?

  Yes, the device is designed for professional installation by a qualified healthcare provider. Implantable pacemakers like this require precise surgical techniques, sterile conditions, and expertise in cardiac electrophysiology to ensure proper placement and function. Non-qualified personnel lack the training to safely handle the device, assess patient suitability, or address potential complications during or after implantation.