Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K954719 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

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  Class II

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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead, and how does it function in the body?

  The Intermedics Model 430-07 is designed to transmit electrical pacing signals from an implanted pulse generator to the heart, helping regulate cardiac rhythm. It uses a bipolar electrode configuration and a passive-fixation mechanism to anchor securely within the endocardial tissue, ensuring stable pacing over time. This makes it ideal for patients requiring long-term cardiac rhythm support.

• Is the Intermedics Model 430-07 intended for reuse, or is it meant for single-use implantation?

  The device is explicitly labeled as sterile and intended for single-use implantation in cardiac procedures. Reuse is not recommended, as it could compromise sterility and performance integrity, potentially leading to complications.

• What materials are used in the construction of the Intermedics Model 430-07, and why are they significant?

  The lead features coradial individually coated conductor coils and a polyurethane insulation sheath, both chosen for durability and biocompatibility. The polyurethane sheath ensures long-term stability within the body, while the coated coils reduce the risk of corrosion or tissue irritation, critical for reliable pacing functionality.

• How should the Intermedics Model 430-07 be stored to maintain its sterility and performance?

  Storage must follow the manufacturer’s guidelines to preserve sterility and performance. Since it is sterile upon packaging, it should remain unopened until use and stored in a clean, dry environment away from direct sunlight or extreme temperatures, as per standard medical device handling protocols.

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

  The Intermedics Model 430-07 received FDA 510(k) clearance (K954719) under traditional review with the Cardiovascular Advisory Committee. This means it was deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for permanent pacemaker electrodes. Clinicians can rely on its compliance with FDA requirements for cardiovascular pacing leads.