Intermedics Polyflex-Model 483-03 Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812990 ↗

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 Polyflex Model 483-03 Lead, and how does it function in a patient’s body?

  The Intermedics Polyflex Model 483-03 Lead is a permanent pacemaker electrode designed to transmit electrical signals between an implanted pacemaker and the heart muscle. It ensures precise regulation of heart rhythm by delivering timed electrical impulses, which helps maintain a stable and effective heartbeat in patients requiring long-term pacing therapy.

• Is this device intended for single-use or can it be reused after implantation?

  The Polyflex Model 483-03 Lead is explicitly supplied as a single-use, sterile device. It is intended for one-time implantation during cardiovascular procedures, and reuse is not recommended or supported by the manufacturer.

• How should this device be stored to maintain its sterility and functionality?

  Since the Polyflex Model 483-03 Lead is sterile upon packaging, it must be stored according to sterile medical device protocols to prevent contamination. This includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

• Does this lead comply with MRI safety standards, and if so, how does that affect its use?

  Yes, the Polyflex Model 483-03 Lead is designed to comply with MRI safety standards for pacemaker leads. This means it is engineered to minimize risks during MRI procedures, though clinicians should still follow manufacturer guidelines and institutional protocols to ensure safe imaging for patients with implanted leads.

• What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians or buyers?

  The Polyflex Model 483-03 Lead received FDA 510(k) clearance (K812990) under the Cardiovascular advisory committee in 1981, with a determination of Substantially Equivalent (SESE) to a predicate device. This means the FDA reviewed it as a traditional submission and found it comparable to an existing approved device, confirming its safety and effectiveness for its intended use in long-term cardiac pacing.