Intermedics Poly Flex Endocardial Atrial Electrode

No FDA recalls on record, checked 22 Oct 2026.

Full name

Intermedics Poly Flex Endocardial Atrial

510(k) Number

K812245 ↗

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 is the primary purpose of the Intermedics Poly Flex Endocardial Atrial Electrode, and how does its design support this function?

  The Intermedics Poly Flex Endocardial Atrial Electrode is designed to deliver electrical stimulation within the atrial chamber of the heart, helping regulate cardiac rhythm in patients who require permanent pacing support. Its flexible polyflex construction allows for precise positioning and stable contact with cardiac tissue, ensuring reliable pacing while minimizing tissue trauma during implantation.

• Is this device intended for reuse, or is it meant to be used only once? How is it supplied to ensure sterility?

  This device is intended for single-use only. It is supplied sterile in its packaging, which is specifically designed for direct implantation during cardiac procedures, eliminating the need for reprocessing or reuse.

• Can this electrode be used in patients who require MRI scans, and if so, under what conditions?

  Yes, the Intermedics Poly Flex Endocardial Atrial Electrode is compatible with MRI environments under specified conditions. However, the exact parameters (e.g., MRI machine type, field strength, and scanning protocols) should be confirmed with the manufacturer or device documentation, as safety depends on adherence to those guidelines.

• What regulatory pathway was followed for FDA clearance of this device, and when was it originally approved?

  The device underwent a Traditional 510(k) review before receiving FDA clearance, with the Cardiovascular (CV) Advisory Committee providing input. It was granted 510(k) clearance (K812245) in 1981, with a decision confirming it as substantially equivalent to a predicate device under FDA regulations (870.3680).

• How is this electrode distributed, and what should clinicians consider when handling or storing it before use?

  The electrode is distributed in sterile packaging designed for direct implantation during cardiac procedures. Clinicians should ensure the packaging remains unopened and intact until use, as it is not intended for reprocessing. Proper storage involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures to maintain sterility and integrity.