Orion 40 Cardiac Stimulator & PMP 200 Programmer

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

510(k) Number

K852641 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• S80 Implantable Cardiac Pacing Lead

  Class III

  FDA 510(k) K854963 Active Cleared 24 Jun 1986

• Bcd Advanced Blood Carioplegia Systems

  Class II

  FDA 510(k) K925369 Active Cleared 26 Mar 1993

• Diria-Progk Immunoassay

  Class I

  FDA 510(k) K832694 Active Cleared 11 Jan 1984

• Stockert 1/4 Bubble Sensor

  Class II

  FDA 510(k) K925541 Active Cleared 2 Feb 1993

• Digoctk 125

  Class II

  FDA 510(k) K800773 Active Cleared 24 Apr 1980

• Renctk

  Class II

  FDA 510(k) K800774 Active Cleared 21 Apr 1980

See all devices from Sorin Biomedica, Fiat, USA, Inc. →

• Is the Orion 40 Cardiac Stimulator designed for reuse after implantation, or is it intended for single-use only?

  The Orion 40 Cardiac Stimulator is explicitly designed for single-use implantation. This means it is not intended to be removed, reused, or reprocessed after initial placement in the patient. The device is supplied sterile, requiring adherence to sterile medical device protocols during handling and implantation.

• How is the Orion 40 Cardiac Stimulator programmed, and what role does the PMP 200 Programmer play in its use?

  The Orion 40 Cardiac Stimulator is programmed and monitored using the dedicated PMP 200 Programmer console, which interfaces wirelessly with the implanted pulse generator. This allows clinicians to adjust pacing parameters and review patient data during in-clinic visits, ensuring optimal cardiac rhythm regulation.

• What storage and handling precautions must be followed for the Orion 40 Cardiac Stimulator to maintain sterility?

  Since the Orion 40 is supplied sterile, it must be stored and handled according to standard sterile medical device protocols. This includes keeping the packaging intact until immediate use, avoiding contamination, and following manufacturer guidelines to preserve sterility before implantation.

• What regulatory pathway was followed for FDA clearance of the Orion 40 Cardiac Stimulator, and what does that mean for its use?

  The Orion 40 Cardiac Stimulator received FDA 510(k) clearance (K852641) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) from the Cardiovascular (CV) Advisory Committee. This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be marketed in the U.S. for its intended use as an implantable pacemaker pulse-generator.