Implantable Programmable Pulse Generat

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

510(k) Number

K842473 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What clinical conditions is this device designed to address and how does it work?

  This device, the Implantable Programmable Pulse Generator, is designed to regulate cardiac rhythm for patients with bradycardia or conduction disorders. It achieves this by delivering programmable electrical impulses to the heart, ensuring consistent pacing. The device adjusts parameters like voltage, pulse frequency, and pulse width to meet individual patient needs, helping maintain a stable heart rhythm.

• Is this device intended for single-use or can it be reused after implantation?

  This device is explicitly supplied as a single-use, sterile component. It is intended for one-time implantation within the body, and reuse is not supported or recommended due to sterility and safety considerations.

• What storage and handling requirements must be followed for this device?

  Since this device is sterile and single-use, storage and handling must strictly comply with sterile medical device protocols. It should be stored in a clean, dry environment, protected from physical damage, and used within the manufacturer’s specified expiration date to ensure safety and efficacy.

• How is this device regulated, and what does that mean for its use?

  This device is regulated under the FDA’s 510(k) clearance process and falls under Class III medical device classification (870.3610). The clearance (e.g., K842473) indicates it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for use in clinical settings.