Polyflex-Model 493-03 Lead

No FDA recalls on record, checked 22 Oct 2026.

Full name

Intermedics Polyflex-Model 493-03 Lead

510(k) Number

K812989 ↗

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 493-03 Lead, and who is it designed for?

  The Intermedics Polyflex-Model 493-03 Lead is a permanent pacemaker electrode designed to transmit electrical impulses from an implanted pacemaker to the heart. It is intended for patients who require cardiac pacing to maintain a normal heart rhythm, particularly those with arrhythmias or conduction system disorders that disrupt proper heart function. This device is not meant for temporary pacing or acute cardiac events.

• Is the Polyflex-Model 493-03 Lead meant for single-use or can it be reused?

  This device is explicitly labeled as single-use only. While it is non-sterile at the time of shipping, it is sterilized prior to use as part of the manufacturer’s preparation process. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

• What storage and handling precautions should be taken with the Polyflex-Model 493-03 Lead?

  The device must be stored and handled according to standard medical device protocols to ensure proper functionality. Since it is sterilized prior to use, it should be kept in its original packaging until implantation. Exposure to moisture, extreme temperatures, or contamination could degrade performance, so adherence to manufacturer guidelines is critical.

• How was the Polyflex-Model 493-03 Lead authorized for use in the U.S., and what regulatory pathway was followed?

  The device was cleared via the FDA’s Traditional 510(k) pathway in 1981 under product code DTB, which classifies it as a Class 3 medical device. The clearance was based on a determination of substantial equivalence to a predicate device, and it remains authorized for cardiovascular applications, specifically for permanent pacemaker electrode use.