Pulse Generator Model 629

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

510(k) Number

K790670 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lead Modification

  Class III

  FDA 510(k) K770135 Active Cleared 7 Feb 1977

• 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 the Pulse Generator Model 629 and how does it function in a clinical setting?

  The Pulse Generator Model 629 is designed as an implantable pacemaker pulse-generator to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is specifically intended for patients with bradycardia or conduction disorders, ensuring consistent pacing signals to maintain proper heart function. The device is surgically implanted by qualified healthcare professionals in a controlled clinical environment.

• Is the Pulse Generator Model 629 intended for single-use or can it be reused after implantation?

  The Pulse Generator Model 629 is supplied as a sterile, single-use component. Once implanted, it is not designed for removal or reuse, as it is intended to remain in place as a permanent solution for the patient’s cardiac pacing needs.

• What safety considerations should be taken into account when using the Pulse Generator Model 629, particularly regarding MRI compatibility?

  The Pulse Generator Model 629 adheres to MRI safety standards as outlined in FDA regulation number 870.3610. This means it has been evaluated for safe use in MRI environments, though specific MRI protocols and precautions should still be followed to ensure patient safety during imaging procedures.

• How is the Pulse Generator Model 629 supplied, and what are the key details about its packaging and handling?

  The Pulse Generator Model 629 is supplied in a sterile package, ensuring it is ready for immediate use in a surgical setting. The device must be handled under sterile conditions by qualified healthcare professionals to maintain its integrity and functionality prior to implantation.