Battery for #229-01 Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802040 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of this battery in a clinical setting?

  This battery is designed exclusively as the power source for the #229-01 Pulse Generator, an implantable cardiac pacemaker system. It provides the electrical energy required to stimulate the heart in patients with bradycardia or conduction disorders, ensuring consistent pacing to maintain a proper heart rhythm. It is not a standalone therapy but a critical component of the pacemaker system.

• How is this battery supplied, and is it intended for single-use or reuse?

  The battery is supplied as a standalone component to be paired with the #229-01 Pulse Generator. The provided specifications do not specify whether it is single-use or reusable, so its intended use depends on the manufacturer’s instructions for the specific pacemaker system. Typically, implantable pacemaker batteries are designed for single-use to ensure reliability and patient safety.

• What regulatory pathway was followed for this device’s clearance, and which committee reviewed it?

  This battery underwent a traditional 510(k) clearance pathway under the FDA’s Class III designation (21 CFR 870.3610), as it is part of an implantable cardiac pacemaker system. The review was conducted by the Cardiovascular (CV) Advisory Committee, which evaluates cardiovascular devices for safety and effectiveness before clearance. The decision was made on September 9, 1980, with a determination of Substantially Equivalent (SESE) to a predicate device.

• Are there any details provided about storage or handling requirements for this battery?

  The provided specifications do not include explicit instructions on storage or handling for this battery. However, as an implantable medical device component, it should be stored according to the manufacturer’s guidelines to maintain integrity, typically in a clean, dry environment away from extreme temperatures or moisture. Always refer to Intermedics’ official documentation for precise storage recommendations.