Pulse Generator Model 208

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

510(k) Number

K781178 ↗

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

• 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

See all devices from Elema-Schonander, Inc. →

• What types of patients is the Pulse Generator Model 208 intended to support, and how does it work?

  The Pulse Generator Model 208 is designed for patients who require pacing support due to cardiac rhythm irregularities. It functions as an implantable pacemaker, delivering controlled electrical impulses to the heart to maintain consistent contractions and ensure proper cardiac function. This is particularly useful for individuals with bradycardia or other conditions causing slow heart rates.

• Is the Pulse Generator Model 208 a single-use or reusable device, and how is it supplied?

  The Pulse Generator Model 208 is reusable and intended for implantable use. It is not a disposable device but rather a long-term component that remains implanted within the patient’s body after surgical placement. The device is supplied as a standalone unit, ready for implantation by a healthcare professional.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The Pulse Generator Model 208 received FDA 510(k) clearance (K781178) under the traditional review pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. This classification confirms it is a Class III, high-risk, life-sustaining device under regulation 870.3610, ensuring rigorous scrutiny for cardiovascular applications. Clinicians can rely on its regulatory history as evidence of compliance with stringent U.S. standards.

• How is the device categorized in terms of medical specialty and regulatory classification?

  The Pulse Generator Model 208 falls under the Cardiovascular medical specialty and is classified as an Implantable Pacemaker Pulse-Generator under FDA product code DXY. Its regulatory designation as a Class III device reflects its critical role in maintaining life-sustaining cardiac function, requiring specialized handling and implantation by trained professionals.