Optima MPT and SPT Pacemakers

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

510(k) Number

K884411 ↗

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 these pacemakers designed for reuse in multiple patients, or are they intended for single-use only?

  The Optima MPT and SPT Pacemakers are explicitly supplied as single-use devices. Each unit is intended for one surgical implantation and is not meant to be reused across patients. This aligns with their sterile packaging and classification as implantable pulse generators for cardiovascular use.

• What types of heart conditions are these pacemakers intended to address, and how do they work?

  These pacemakers are designed to regulate abnormal heart rhythms, specifically addressing bradycardia or conduction disorders. They function by delivering controlled electrical impulses to the heart muscle, ensuring proper pacing and maintaining regular cardiac rhythm during periods when the heart’s natural conduction system fails.

• How are these devices packaged and stored for clinical use?

  The Optima MPT and SPT Pacemakers are supplied in sterile packaging, which is essential for surgical implantation. Clinicians should store them in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve sterility and functionality until use. The sterile barrier ensures safety for direct implantation.

• What regulatory pathway was followed for FDA clearance of these pacemakers, and what does that mean for clinicians?

  The Optima MPT and SPT Pacemakers were cleared through the FDA’s 510(k) process, specifically under the traditional review route with a decision of