Myopore Unipolar Models 1117 & 1118 Pace Leads

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

Full name

Myopore(Tm) Unipolar Models 1117 & 1118 Pace Leads

510(k) Number

K896443 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Possis Medical, Inc. →

• Are these pace leads designed for reuse in multiple patients, or are they intended for single-use only?

  The Myopore Unipolar Models 1117 & 1118 Pace Leads are explicitly supplied sterile and intended for single-use implantation in cardiac pacing procedures. Reuse is not recommended, as this could compromise sterility and patient safety. Always follow sterile medical device handling protocols before use.

• What types of arrhythmias or conduction disorders are these leads typically used to treat?

  These leads are permanent pacemaker electrodes designed to deliver electrical impulses to the myocardium for chronic pacing therapy. They support patients with arrhythmias or conduction disorders requiring long-term cardiac pacing, such as bradycardia, heart block, or other conditions where consistent pacing is necessary.

• How should these leads be stored to maintain their sterility before use?

  Since these leads are supplied sterile, they must be stored and handled according to sterile medical device protocols to preserve integrity. This includes keeping them in their original packaging, away from contamination, and following manufacturer guidelines to prevent compromise before implantation.

• What regulatory pathway was followed for FDA clearance of these pace leads?

  The Myopore Unipolar Models 1117 & 1118 Pace Leads received FDA 510(k) clearance (K896443) under the traditional review pathway, with a decision of *Substantially Equivalent* (SESE). They fall under product code DTB and are classified as Class III medical devices, regulated under 21 CFR 870.3680 for permanent pacemaker electrodes.

• What are the key differences between Model 1117 and Model 1118?

  While the provided data does not specify exact differences between the two models, both are unipolar permanent pacemaker leads intended for cardiovascular implantation. The distinction likely lies in electrode design, lead length, or fixation mechanism—common variations in pacing leads. For precise sizing or model-specific features, refer to the manufacturer’s technical documentation or consult a cardiology specialist.