Astra 2, Astra 3, 4 & 6 Implantable Pacemaker Pulse-Generator

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

Full name

Astra 2, Astra 3, 4 & 6

510(k) Number

K842394 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What specific cardiac conditions are the Astra 2, Astra 3, 4 & 6 pacemakers designed to treat?

  The Astra series pacemakers are designed to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. They deliver electrical impulses to stimulate the heart muscle, ensuring proper pacing when the natural pacemaker is insufficient or malfunctioning. This makes them suitable for patients whose heartbeats are too slow or irregular due to conduction issues.

• Are the Astra 2, Astra 3, 4 & 6 pacemakers intended for single-use or can they be reused?

  The Astra 2, Astra 3, 4 & 6 pacemakers are supplied sterile and explicitly intended for single-use only. Reuse is not recommended, and proper handling and storage as per manufacturer guidelines must be followed to maintain sterility and device integrity.

• What regulatory pathway was followed for the Astra 2, Astra 3, 4 & 6 pacemakers, and how does this affect their use?

  The Astra series pacemakers were cleared under the FDA’s 510(k) pathway (K842394) in 1984, with a classification as Class III medical devices. This means they were determined to be substantially equivalent to a legally marketed predicate device at the time of clearance. The clearance was filed under product code DXY and reviewed by the Cardiovascular (CV) Advisory Committee. While this indicates regulatory approval, it does not imply ongoing changes to their intended use or clinical indications.

• How should the Astra 2, Astra 3, 4 & 6 pacemakers be stored before implantation?

  Since these pacemakers are sterile and intended for single-use, they must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage conditions typically include protection from moisture, extreme temperatures, and physical damage, as outlined in the accompanying documentation. Always refer to the packaging instructions for specific storage requirements.

• What types of settings or specialties are these pacemakers primarily used in?

  The Astra 2, Astra 3, 4 & 6 pacemakers are intended for use in cardiovascular settings, such as hospitals, cardiac clinics, or electrophysiology labs. They are designed for surgical implantation by trained professionals, including cardiologists or cardiac surgeons, to address bradycardia or conduction disorders in patients.