Pacing Lead #PMA F 860

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

510(k) Number

K830457 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

• Opus Models 4033 and 4034 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K894267 Active Cleared 20 Sep 1989

See all devices from Ela Medical, Inc. →

• What is the primary purpose of the PACING LEAD #PMA F 860 and how does it function in the body?

  The PACING LEAD #PMA F 860 is designed as a permanent pacemaker electrode to deliver electrical impulses to the heart, ensuring proper cardiac rhythm when the natural pacemaker fails. It stimulates contractions in heart chambers to maintain regular heart function for patients requiring chronic cardiac rhythm management. This is achieved through surgical implantation, where the lead is placed inside the heart to deliver timed electrical signals.

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

  The PACING LEAD #PMA F 860 is sterile upon supply and intended for single-use only. Once implanted surgically into the heart, it is not designed for removal or reuse. Sterility ensures patient safety during the initial procedure, and single-use aligns with best practices for implanted cardiac devices to prevent infection or degradation over time.

• What regulatory pathway does this device follow, and how does that affect its use in clinical settings?

  This device follows the FDA 510(k) clearance pathway, specifically under Traditional Review with a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. The clearance (K830457) confirms it meets FDA standards for safety and performance as a Permanent Pacemaker Electrode, ensuring compliance with 21 CFR 870.3680. Clinicians can rely on this approval to validate its use in cardiac rhythm management procedures.

• Are there multiple sizes or models of this pacing lead, and how would a clinician determine the correct one for a patient?

  The data includes multiple FEI (Final Establishment Identification) numbers (e.g., 3002618605, 2017865), which likely correspond to different batch or lot identifiers rather than distinct sizes or models. However, the product code DTB and registration numbers suggest variations may exist for specific patient anatomies or pacing needs. Clinicians should consult the manufacturer’s documentation or technical specifications to match the lead’s design (e.g., tip configuration, electrode placement) to the patient’s cardiac anatomy and pacing requirements.

• How should the PACING LEAD #PMA F 860 be stored before use, and what precautions should be taken?

  While the data does not specify storage conditions explicitly, as a sterile, single-use device, it should be stored in its original packaging in a clean, dry environment protected from contamination, moisture, or extreme temperatures. The manufacturer’s instructions (not provided here) would detail shelf-life, temperature ranges, and any handling precautions to maintain sterility and functionality until surgical implantation.