Pellethan Adhesive on Polyurethane Leads-MODI

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

Full name

New Adhesive, Pellethan on Polyurethane Leads-Modi

510(k) Number

K893041 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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

• 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

• Unipolar Upsizing Adaptor

  Class II

  FDA 510(k) K912773 Active Cleared 23 Oct 1991

See all devices from Telectronics Pacing Systems, Inc. →

• What is the primary purpose of the Pellethan adhesive on these polyurethane leads, and how does it differ from standard pacemaker leads?

  The Pellethan adhesive is designed to enhance the secure attachment of pacemaker electrodes during implantation, reducing the risk of lead displacement over time. Unlike standard leads, this adhesive formulation maintains electrical conductivity while improving fixation stability within the cardiovascular system, supporting long-term pacing therapy without compromising biocompatibility.

• Is this device intended for reuse, or is it meant to be used only once per patient?

  This device is explicitly supplied as a sterile, single-use component. It must be handled under aseptic conditions and is not intended for reuse, adhering to standard sterile medical device protocols for invasive cardiovascular procedures.

• How should this device be stored, and what precautions should be taken during handling?

  Storage follows standard sterile medical device protocols, though specific conditions (e.g., temperature, humidity) are not detailed in the data. Since it is invasive and single-use, it must be kept in its original packaging until immediately before use, and handled with aseptic techniques to prevent contamination.

• What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this submission?

  This device was cleared via the traditional 510(k) review pathway (K893041) and was evaluated by the Cardiovascular (CV) Advisory Committee as part of the submission process. The classification is Class III under 21 CFR 870.3680, reflecting its role as a permanent pacemaker electrode.

• Are there any known limitations regarding MRI compatibility for this device?

  The provided data does not specify MRI safety information, meaning its compatibility with MRI procedures is not addressed. Clinicians should consult manufacturer guidelines or contact Telectronics Pacing Systems directly for MRI-related precautions before exposing patients to magnetic resonance imaging.