Medtronic Models 8316, 8317, 8318 Pulse Generators - 8318 Pulse Generators

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

510(k) Number

K855147 ↗

FDA Product Code

DXY

Models / Variants

8316

8317

8318 Pulse Generators

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pulse Generators

  Class III

  FDA 510(k) K772357 Active Cleared 17 Jan 1978

• Medtronic Pulse Generator

  Class III

  FDA 510(k) K811123 Active Cleared 27 May 1981

• Sutureless Myocardial Pacing Lead

  Class III

  FDA 510(k) K780446 Active Cleared 19 May 1978

• APTUS Heli-FX® HG-18-90-42

  Class II

  GUDID on market

• Heli-FX™ Thoracic EndoAnchor™ System HG-18-90-22

  Class II

  GUDID on market

• Heli-FX™ Ancillary EndoAnchor™ Cassette EC-05

  Class II

  GUDID on market

See all devices from Medtronic Vascular, Inc. →

• What is the primary purpose of the Medtronic Models 8316, 8317, and 8318 Pulse Generators, and how do they function in a clinical setting?

  These pulse generators are designed as implantable pacemaker devices to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. They are intended for patients requiring chronic pacing support, helping to maintain proper heart rate and rhythm in conditions like bradycardia or heart block. The devices are surgically implanted and work by stimulating the heart muscle electrically when the natural pacemaker fails.

• Are these pulse generators single-use or reusable, and what does that mean for clinical workflows?

  The Medtronic Models 8316, 8317, and 8318 Pulse Generators are intended for single-use implantation after initial activation. Once implanted, they are not designed for removal or reuse. Clinicians must follow sterile procedures during implantation, as the devices are not sterilized for repeated use. This aligns with standard practices for implantable cardiac devices to ensure patient safety and infection control.

• What regulatory pathway did Medtronic follow to bring these pulse generators to market, and what does that imply about their safety and efficacy?

  These devices were cleared through the FDA’s 510(k) process, specifically under K-number K855147, filed in 1985 and cleared in 1986. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and classified as Substantially Equivalent (SESE) to a predicate device, indicating that Medtronic demonstrated the new model met the same safety and performance criteria as an existing, cleared pacemaker. This pathway is reserved for high-risk, life-sustaining devices like implantable pulse generators, ensuring rigorous evaluation.

• How are these pulse generators supplied, and what storage or handling considerations should clinicians keep in mind before implantation?

  While the exact packaging details aren’t specified, as implantable medical devices, these pulse generators are likely supplied in sterile, sealed packaging to prevent contamination before use. Clinicians should store them in a clean, dry environment away from direct sunlight or extreme temperatures, adhering to manufacturer guidelines to preserve sterility and functionality. Proper handling—such as avoiding exposure to moisture or physical damage—is critical to ensure the device remains operational post-implantation.

• What product codes or classifications apply to these pulse generators, and how does that affect their use in healthcare settings?

  These devices fall under FDA Product Code DXY, which categorizes them as Implantable Pacemaker Pulse-Generators. This classification aligns with their Class III designation, reflecting their high-risk nature and the need for stringent regulatory oversight. Clinicians and purchasing teams should reference this code when ordering supplies or integrating the device into electronic health records, as it ensures compatibility with billing systems and regulatory tracking for cardiovascular implantable electronic devices (CIEDs).