Siemens-Elema Pulse Generator 625

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

510(k) Number

K801508 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Siemens Elema AB →

• What is the primary purpose of the Siemens-Elema Pulse Generator 625 and how does it function in a clinical setting?

  The Siemens-Elema Pulse Generator 625 is an implantable pacemaker designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the body’s natural electrical activity is insufficient. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper cardiac function by stimulating contractions when needed.

• Is the Siemens-Elema Pulse Generator 625 intended for single-use or reusable applications, and how should it be handled post-implantation?

  The device is designed for single-use or reusable implantation, as noted in regulatory submissions. While the data does not specify reuse protocols, its classification as a high-risk, life-sustaining device implies strict adherence to sterile handling and regulatory guidelines during and after implantation. Always follow manufacturer instructions and local medical protocols for proper use.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians or buyers?

  The Siemens-Elema Pulse Generator 625 received FDA clearance via a Traditional 510(k) pathway (K801508) under Regulation 870.3610, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it met safety and effectiveness standards comparable to existing pacemakers, ensuring it adheres to rigorous medical device regulations for implantable cardiac devices. Clinicians and buyers can rely on this clearance as evidence of compliance with U.S. regulatory requirements.

• Are there specific size or model variations for the Siemens-Elema Pulse Generator 625, or is it a single standardized unit?

  The provided data does not specify size variations, model numbers beyond the core designation (625), or MRI safety details for this device. As an implantable pacemaker pulse-generator, it would typically be tailored to patient anatomy during implantation, but exact dimensions or model distinctions would require consulting the original manufacturer documentation or technical specifications.

• How should the Siemens-Elema Pulse Generator 625 be stored, and what sterility guarantees are associated with it?

  The device is supplied sterile, which is standard for implantable medical devices to prevent infection. Storage instructions are not detailed in the data, but sterile pacemakers generally require protection from contamination—typically in sealed, sterile packaging until immediate use. Always follow the manufacturer’s storage guidelines to maintain sterility and functionality.