Pulse Generator, Cardiac 20U

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

Full name

Generator, Pulse, Cardiac 20U

510(k) Number

K770656 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Micropulse 26U Pulse Generator

  Class III

  FDA 510(k) K771987 Active Cleared 2 Nov 1977

• Edwards Pacemaker 30 Unipolar Generator

  Class III

  FDA 510(k) K791751 Active Cleared 26 Sep 1979

• Micropulse 22S Pacemaker

  Class III

  FDA 510(k) K780780 Active Cleared 30 Jun 1978

• Prolith 23S Pacemaker

  Class III

  FDA 510(k) K781042 Active Cleared 27 Jul 1978

• Generator, Pulse, Cardiac 2LU

  Class III

  FDA 510(k) K770657 Active Cleared 26 Apr 1977

• Micropulse 22U

  Class III

  FDA 510(k) K780091 Active Cleared 30 Jan 1978

See all devices from Edwards Pacemaker Systems →

• What types of heart rhythm disorders can the Pulse Generator, Cardiac 20U address, and how does it work?

  The Pulse Generator, Cardiac 20U is designed to address both intermittent and continuous cardiac rhythm disorders by providing electrical stimulation to the heart. It functions as a substitute for the heart’s natural pacemaker system through three pacing modes: triggered, inhibited, or asynchronous. This means it can respond to the heart’s natural electrical activity (triggered), suppress unwanted signals (inhibited), or deliver pulses independently (asynchronous) to maintain a consistent heart rhythm.

• Is this device intended for reuse, or is it meant to be implanted once and then discarded?

  The Pulse Generator, Cardiac 20U is explicitly intended for single-use only. Once implanted surgically within the body, it is not designed to be removed or reused. This aligns with its classification as an implantable device meant to provide long-term cardiac support.

• How is this device regulated in the U.S., and what does the FDA’s clearance mean for its use?

  The Pulse Generator, Cardiac 20U is regulated under FDA 510(k) clearance (K770656) with a Substantially Equivalent (SESE) determination. This means the FDA has determined it is as safe and effective as a legally marketed device that served as its predicate. The device falls under Regulation 870.3610 and is classified under the DXY product code, indicating its use in cardiovascular applications. The clearance does not imply an indication for specific conditions but confirms the device meets regulatory standards for safety and performance.

• What storage or handling considerations should be taken into account before implantation?

  While the provided data does not specify exact storage conditions, as a single-use, implantable medical device, the Pulse Generator, Cardiac 20U should be stored in a manner that preserves its sterility and integrity until use. This typically includes keeping it in its original, sealed packaging away from extreme temperatures, moisture, or contamination. Always follow the manufacturer’s (Edwards Pacemaker Systems) specific storage instructions included with the device.

• Does this device come in different sizes or models, or is it a single standardized unit?

  The data provided does not list multiple sizes or models for the Pulse Generator, Cardiac 20U, suggesting it is offered as a single standardized unit. However, pacemaker systems often include compatible leads or other components that may vary by patient needs. For exact sizing or model variations, refer to the manufacturer’s catalog or technical documentation, as this device is designed to be implanted surgically and paired with appropriate leads for individual patient requirements.