Trios - M

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853057 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Biotronik DN Unipolar PE-60/4-DN Electrode

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• Pulse Generator

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  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

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  FDA 510(k) K863480 Active Cleared 23 Sep 1986

See all devices from Biotronik Sales, Inc. →

• What types of patients is the TRIOS-M pacemaker designed to treat, and how does it work?

  The TRIOS-M is designed for patients with single-chamber pacing needs, such as those experiencing sinus node dysfunction or bradycardia, where the heart’s natural rhythm is insufficient. It regulates cardiac rhythm by delivering electrical impulses to the heart when spontaneous contractions are too slow or irregular, ensuring consistent pacing to maintain proper heart function. The device is implanted subcutaneously in the chest and operates as a long-term solution.

• Is the TRIOS-M pacemaker intended for reuse, or is it single-use only?

  The TRIOS-M is sterile and intended for single-patient use only. It must be handled in a controlled environment to preserve sterility, as it is not designed for reuse or reprocessing. This ensures patient safety and compliance with medical device standards.

• What precautions should be taken when a patient with a TRIOS-M pacemaker undergoes MRI imaging?

  The TRIOS-M is not MRI-safe, meaning it should not be exposed to MRI procedures without proper shielding. Patients with this device must avoid MRI scans unless specifically approved with appropriate protective measures, as the electromagnetic fields could interfere with the pacemaker’s function or cause damage.

• How is the TRIOS-M pacemaker supplied, and what should be considered during storage?

  The TRIOS-M is supplied sterile and ready for implantation, requiring careful handling to maintain sterility. Since it is intended for single-patient use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, until immediate use. Proper storage ensures the device remains functional and uncontaminated.