Permanent Myocardial Leads MP Series

• • Terminated Z-2333-2008 FDA Unclassified (pre-2012) ·initiated 29 Jan 2008

  The O-rings are over tolerance making it hard to connect the leads to the pacemaker.

510(k) Number

K872971 ↗

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. →

• Are these leads reusable or intended for single-use only, and why does that matter for my procedure planning?

  The Permanent Myocardial Leads MP Series are intended for single-use only and supplied sterile. This design ensures patient safety by eliminating cross-contamination risks and maintaining sterility, which is critical for long-term implantation in cardiac pacing procedures. Single-use also simplifies inventory management and reduces the need for reprocessing or sterilization between cases.

• What storage requirements should I follow to keep these leads sterile and functional until use?

  These leads must be stored according to sterile medical device protocols to preserve their integrity. Since they are supplied sterile, they should remain in their original packaging until immediately before implantation. Avoid exposure to moisture, extreme temperatures, or contamination, as these could compromise sterility or performance. Always check the packaging for expiration or sterility indicators before use.

• How do I know which model or reference code is compatible with my pacemaker system?

  The MP Series includes multiple reference codes (listed under `fei_number` and `registration_number` in the data) to ensure compatibility with various pacemaker systems. These codes correspond to specific lead configurations, so you should verify the exact model number or code required by your implantable pulse generator’s manufacturer. Contact Oscor Medical Corp. or refer to their technical documentation for precise matching guidance.

• Why is this device classified as Class III, and what does that mean for my clinical workflow?

  The Permanent Myocardial Leads MP Series are classified as Class III devices under FDA regulations due to their role in life-sustaining or supporting functions (long-term cardiac pacing). This classification means the device undergoes rigorous review for safety and effectiveness, ensuring high reliability for chronic implantation. Clinically, this classification implies thorough pre-procedure validation (e.g., imaging, lead positioning) and adherence to sterile techniques, as the device’s performance directly impacts patient outcomes.