Optima MPT Series III Pacemaker, Unipolar/Bipolar

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

510(k) Number

K894185 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 100 cm Permanent Pacing Lead Models

  Class III

  FDA 510(k) K911273 Active Cleared 28 Aug 1991

• Pellethan Adhesive on Polyurethane Leads-MODI

  Class III

  FDA 510(k) K893041 Active Cleared 14 Nov 1989

• Optima MPT Model 5281E and Model 5282E

  Class III

  FDA 510(k) K897116 Active Cleared 14 Mar 1990

• Telectronics Pacing Systems Vs-1 to 6mm Upsizing

  Class II

  FDA 510(k) K895971 Active Cleared 22 Feb 1990

• Bifurcated Vs-1 to Vs-1 Lead Adaptor

  Class II

  FDA 510(k) K910112 Active Cleared 25 Feb 1991

• Vs-1 Lead Ext. 033-302, 4.75mm 033-260, 033-458

  Class III

  FDA 510(k) K901402 Active Cleared 12 Jun 1990

See all devices from Telectronics Pacing Systems, Inc. →

• What types of heart conditions is the Optima MPT Series III Pacemaker designed to address, and how does it work?

  The Optima MPT Series III Pacemaker is designed to manage bradycardia (slow heart rate) and conduction disorders by delivering unipolar or bipolar electrical stimulation to regulate heart rhythm. It achieves this through programmable pacing modes and rates, ensuring consistent cardiac output for patients who require artificial cardiac pacing.

• Is the Optima MPT Series III Pacemaker intended for reuse, or is it meant to be implanted once and discarded?

  The device is explicitly labeled as sterile and intended for single-use implantation only. After use, it should not be reused or reprocessed, as this could compromise patient safety and device integrity.

• What storage instructions should be followed for the Optima MPT Series III Pacemaker before implantation?

  The device must be stored according to the manufacturer’s instructions provided by Telectronics Pacing Systems. While the data does not specify exact storage conditions (e.g., temperature or humidity), adherence to the manufacturer’s guidelines is critical to maintain sterility and functionality prior to use.

• Can this pacemaker be used in patients who require MRI scans, or is it MRI-compatible?

  The Optima MPT Series III Pacemaker is not MRI-compatible. Patients with this device should avoid MRI procedures, as the magnetic fields could interfere with its operation or cause harm.

• How do I confirm the regulatory clearance status of this device for use in my facility?

  This device holds a Traditional 510(k) clearance (K894185) under FDA regulation 21 CFR 870.3610, with substantial equivalence determined by the Cardiovascular (CV) Advisory Committee. For verification, you may reference the FDA’s OpenFDA database using the device name or the clearance number. Always ensure compliance with local regulations before use.