Sorin Biomedica Orion 30/A Cardiac Stimulator & Pacemaker

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

Full name

Sorin Biomedica Orion 30/A Cardiac Stimulator & Pm

510(k) Number

K851365 ↗

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 Sorin Biomedica, Fiat, USA, Inc. →

• What is the Orion 30/A Cardiac Stimulator & PM primarily used for in clinical practice?

  The Orion 30/A is designed to regulate cardiac rhythm by delivering electrical pacing impulses to the heart. It is intended for patients with bradycardia or other cardiac conduction disorders, providing pacing therapy to maintain a stable heart rate when the natural conduction system is impaired.

• Is the Orion 30/A Cardiac Stimulator & PM intended for single-use or reusable applications?

  The Orion 30/A is supplied sterile and explicitly intended for single-use only. It requires professional medical expertise for implantation and is not designed for reuse, aligning with standard sterile medical device protocols.

• How should the Orion 30/A Cardiac Stimulator & PM be stored to maintain its integrity?

  Since the device is sterile and single-use, storage must follow sterile medical device protocols. It should be kept in its original packaging, protected from contamination, moisture, and physical damage, and stored in a clean, dry environment as specified for implantable devices.

• What regulatory pathway does the Orion 30/A Cardiac Stimulator & PM follow, and which advisory committee was involved?

  The Orion 30/A was cleared under the FDA 510(k) pathway (K851365) with a decision of *Substantially Equivalent* (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III device under 21 CFR 870.3610.