Model 439-07 and 439-09 Lifeline Myocardial Lead

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K880551 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• Are these leads designed for reuse in multiple patients or intended as single-use implants?

  These leads are explicitly designed for single-use implantation in cardiac pacing procedures. They are supplied sterile and intended for use in one patient only, per manufacturer instructions. Reuse is not recommended to maintain sterility and functionality.

• What storage conditions should be followed to preserve sterility and functionality of the Model 439-07 and 439-09 leads?

  The leads must be stored according to the manufacturer’s guidelines to ensure sterility and performance. While specific conditions aren’t detailed here, typical best practices for sterile, single-use medical devices—such as keeping them in sealed, unopened packaging, away from extreme temperatures, and protecting from moisture or contamination—should be followed. Always refer to Intermedics’ instructions for precise storage requirements.

• What distinguishes the Model 439-07 from the Model 439-09 in terms of clinical application?

  The distinction between the Model 439-07 and Model 439-09 is not explicitly detailed in the provided data, but both are classified as *Permanent Pacemaker Electrodes* for delivering electrical stimulation to the myocardium. Differences in design (e.g., lead length, electrode configuration, or pacing thresholds) would typically be specified in the manufacturer’s documentation. For precise clinical application guidance, consult Intermedics’ technical literature or product specifications.

• How were these leads evaluated for regulatory clearance, and what committee reviewed their submission?

  The Model 439-07 and 439-09 leads underwent a Traditional 510(k) review process with the FDA, classified under the Cardiovascular (CV) advisory committee. The submission was deemed *substantially equivalent* to predicate devices, as indicated by the decision code SESE. The review panel assessed their safety and effectiveness for use as permanent pacemaker electrodes, ensuring compliance with FDA regulations for Class III devices.