Intermedics Poly Flex Endocardial Pacing Electrode

No FDA recalls on record, checked 22 Oct 2026.

Full name

Intermedics Poly Flex Endocardial Pacing

510(k) Number

K811106 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What types of patients is this device designed to support with pacing therapy?

  This device is designed for patients with bradycardia or conduction disorders who require consistent pacing support. It delivers electrical stimulation to the heart’s inner chambers (endocardial pacing) to regulate cardiac rhythm, specifically positioned within the right ventricle or atrium via single-use implantation.

• How is the Intermedics Poly Flex Endocardial Pacing Electrode supplied and prepared for use?

  The device is supplied sterile and pre-packaged for surgical use, ensuring readiness for immediate implantation. It is intended for single-use only, meaning each electrode is designed for one-time implantation via a catheter, eliminating the need for reprocessing.

• Are there different models available, and how do they differ?

  Yes, multiple model references are available for customization, allowing for tailored selection based on clinical needs. The exact variations are not detailed in the data, but the availability of different references suggests options for specific anatomical or procedural requirements.

• Can this device be used in patients who require MRI scans?

  Yes, this device is compatible with MRI environments under specified conditions, which means it can be used in patients who require magnetic resonance imaging. However, the exact MRI safety parameters or restrictions would need to be reviewed in the device’s labeling or instructions for use.

• What regulatory pathway was followed for this device’s approval, and how does that affect its use?

  The device was cleared through the FDA’s 510(k) pathway under the Cardiovascular advisory committee, with a decision of *Substantially Equivalent* (SESE). This means it was determined to be as safe and effective as a legally marketed predicate device, ensuring its compliance with FDA standards for permanent pacemaker electrodes. The classification as Class III under 21 CFR 870.3680 also governs its manufacturing and quality controls.