Lead Modification

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

510(k) Number

K770135 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pulse Generator Model 629

  Class III

  FDA 510(k) K790670 Active Cleared 27 Jun 1979

• Puck 90M

  Class II

  FDA 510(k) K903576 Active Cleared 4 Sep 1990

• Sep Programmer for Puck U & Ud Filmchang

  Class II

  FDA 510(k) K842903 Active Cleared 21 Aug 1984

• Pulse Generator Model 637

  Class III

  FDA 510(k) K790792 Active Cleared 12 Oct 1979

• Sep Programmer Sep-M/Single-Plane &

  Class II

  FDA 510(k) K840389 Active Cleared 21 Feb 1984

• Pacemaker 208S

  Class III

  FDA 510(k) K770005 Active Cleared 24 Feb 1977

See all devices from Elema-Schonander, Inc. →

• What is the primary purpose of this Lead Modification in cardiac rhythm management systems?

  The Lead Modification is designed to adjust or adapt pacemaker leads so they can be properly connected to implantable pulse generators. This ensures reliable electrical conduction and pacing functionality within cardiac rhythm management systems, allowing for compatibility between leads and generators that may not otherwise interface correctly.

• Is this device intended for single-use or can it be reused in multiple procedures?

  This Lead Modification is explicitly described as a reusable component, meaning it is intended for use in multiple clinical procedures after proper cleaning and maintenance. It is not classified as a single-use device.

• How is this device regulated, and what does that mean for its use in clinical settings?

  The Lead Modification is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K770135, and falls under Device Classification DXY for cardiovascular devices. This means it has been determined to be substantially equivalent to a legally marketed device and is approved for use in clinical settings where pacemaker lead modifications are required for compatibility with pulse generators.

• What types of clinical settings or specialties would typically use this Lead Modification?

  This device is intended for use in clinical settings where pacemaker leads need modification to interface with implantable pulse generators, such as electrophysiology labs, cardiac catheterization labs, or operating rooms during cardiac implant procedures. It is specifically associated with cardiovascular specialties, as indicated by its regulatory classification and advisory committee designation.