Pulse Generator 678L

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

510(k) Number

K841233 ↗

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 Pulse Generator 678L and how does it function in a clinical setting?

  The Pulse Generator 678L is designed as an implantable pacemaker to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is specifically intended for patients with bradycardia or conduction disorders, ensuring consistent pacing to maintain proper heart function. Since it is surgically implanted, it provides continuous, reliable pacing without the need for external devices.

• Is the Pulse Generator 678L intended for reuse, or is it meant to be used only once after implantation?

  The Pulse Generator 678L is sterile for single-use only and is not designed for reuse. It must be implanted directly after opening the sterile packaging to maintain its sterile integrity and functionality. Reusing it would violate manufacturer guidelines and compromise patient safety.

• Can this device be used in patients who require MRI scans, or does it have any MRI-related restrictions?

  The Pulse Generator 678L is non-MRI-compatible, meaning it should not be used in patients who require MRI scans. The strong magnetic fields generated during MRI procedures can interfere with the device’s operation or cause damage. Always consult manufacturer guidelines and clinical protocols before considering MRI for patients with this implanted device.

• How should the Pulse Generator 678L be stored to ensure it remains functional and sterile before implantation?

  The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping it in its original, sealed packaging in a clean, dry environment away from extreme temperatures or direct sunlight. Never open or handle the device until immediately before implantation to avoid contamination or damage.

• What regulatory pathway did the Pulse Generator 678L follow to gain market authorization in the U.S., and which advisory committee was involved?

  The Pulse Generator 678L received FDA clearance through a Traditional 510(k) pathway, classified as a Class III device under regulation 870.3610. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device. This process ensures the device meets safety and effectiveness standards for implantable pacemakers.