Optima MPT and SPT Pacemakers

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

510(k) Number

K891231 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• Are the Optima MPT and SPT Pacemakers designed for reuse, or are they intended for single-use only?

  The Optima MPT and SPT Pacemakers are supplied sterile and intended for single-use only, as explicitly stated in the device description. This aligns with standard sterile medical device protocols to ensure patient safety and prevent contamination.

• What types of cardiac conditions are these pacemakers intended to address?

  These pacemakers are designed for patients with bradycardia or other cardiac conduction disorders that require artificial pacing. They regulate heart rhythm by delivering electrical impulses to the heart muscle, ensuring proper cardiac function in patients with these specific conditions.

• How should the Optima MPT and SPT Pacemakers be stored, and what precautions should be taken?

  The devices must be stored and handled according to sterile medical device protocols, as noted in the description. This ensures they remain uncontaminated and ready for implantation. Proper storage conditions are critical to maintaining sterility and device integrity before use.

• Can these pacemakers be used in patients who require MRI scans, or are there specific restrictions?

  The Optima MPT and SPT Pacemakers are not MRI-compatible without specific manufacturer guidance. This means they should not be used in patients who require MRI scans unless the manufacturer provides explicit approval or instructions for safe use in such scenarios.

• What regulatory pathway was followed for the FDA clearance of these pacemakers, and which committee reviewed the submission?

  The Optima MPT and SPT Pacemakers were cleared through the FDA’s 510(k) pathway, specifically under the traditional review process, with a decision code of SESE (Substantially Equivalent). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, as indicated by the advisory committee description and product code.