Permanent Pacing Pad Modification

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

510(k) Number

K915008 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Implant Pacing Lead Tined #3390, Modification

  Class III

  FDA 510(k) K913203 Active Cleared 23 Sep 1991

• Miscellaneous Pacing Lead

  Class II

  FDA 510(k) K925168 Active Cleared 3 May 1994

• Pacer Sensing Analyzer (Psa 100)

  Class II

  FDA 510(k) K882327 Active Cleared 6 Oct 1988

• Implant Pacemaker Lead, Tined

  Class III

  FDA 510(k) K913201 Active Cleared 23 Sep 1991

• Model Py...u Unipolar & Bipolar Pacing Lead

  Class III

  FDA 510(k) K870034 Active Cleared 3 Mar 1987

• Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir

  Class II

  FDA 510(k) K850622 Active Cleared 10 Apr 1985

See all devices from Oscor Medical Corp. →

• What is the primary purpose of the Permanent Pacemaker Electrode Modification, and how does it differ from a standard permanent pacemaker electrode?

  The Permanent Pacemaker Electrode Modification is designed to upgrade or adapt existing pacing systems for patients who require cardiac rhythm management. Unlike standard electrodes, this modification is specifically intended to be integrated into pre-existing pacemaker systems to provide electrical stimulation to the heart when the natural conduction system is impaired. It ensures continued proper pacing without requiring a full electrode replacement.

• Is this device meant for reuse, or is it intended for single-use only? How does this affect its sterility?

  This device is explicitly intended for single-use only, as stated in the regulatory data. Because it is supplied sterile, it should not be reused after a single procedure to maintain patient safety and prevent infection. Sterility is a critical factor, so proper handling and disposal after use are essential.

• What regulatory pathway was followed for this device, and what does the classification as a Class III device imply?

  This device was cleared through the FDA 510(k) pathway under clearance number K915008, with a decision of Substantially Equivalent to a predicate device. Being classified as a Class III device (870.3680) means it carries higher regulatory scrutiny due to its role in sustaining life or supporting life-sustaining functions, ensuring rigorous safety and effectiveness standards are met before approval.

• How is this modification supplied, and what should clinicians consider when storing it?

  The device is supplied sterile and packaged for single-use, meaning it comes ready for immediate use without additional sterilization. Clinicians should store it in a clean, dry environment, protected from extreme temperatures and moisture, to preserve sterility and functionality until use. Always follow manufacturer guidelines for storage conditions to ensure optimal performance.