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Pellethane 75D

FDA 510(k)

Class III (US FDA 510(k))

510(k) K940039

by Medtronic Vascular

Identifiers

510(k) Number
K940039 FDA 510(k)
FDA Product Code
DXY FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3610 FDA 510(k)
Regulation Number
870.3610 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

The Pellethane 75D is a polyurethane-based material used as a coating for implantable pacemaker pulse generators, providing durability and biocompatibility for long-term cardiac applications. Classified as a polymeric coating within the context of implantable cardiovascular devices, it ensures electrical insulation and mechanical stability for the underlying electronics.

This material is supplied as a sterile, reusable component for manufacturing pacemaker pulse generators, adhering to FDA 510(k) clearance (K940039) under the Cardiovascular advisory committee. It is intended for use in Class III medical devices, regulated under 21 CFR 870.3610, and must comply with strict manufacturing and sterility standards for implantable cardiac devices. No MRI safety information is specified.

Frequently asked questions

What is the primary purpose of Pellethane 75D in pacemaker manufacturing, and how does it contribute to device performance?

Pellethane 75D is a polyurethane-based coating used specifically for implantable pacemaker pulse generators. It provides electrical insulation and mechanical stability to protect the underlying electronics, ensuring long-term durability and biocompatibility for cardiac applications. This coating helps maintain device integrity over extended periods within the body.

Is Pellethane 75D intended for direct patient use, or is it a component used in manufacturing other medical devices?

Pellethane 75D is not a standalone patient-use device. It is supplied as a sterile, reusable component for manufacturing pacemaker pulse generators, adhering to strict regulatory standards for implantable cardiovascular devices. It is not implanted directly but serves as a critical material in the construction of Class III pacemaker systems.

What regulatory pathway was followed for Pellethane 75D’s FDA clearance, and what does this imply for its use in medical devices?

Pellethane 75D received FDA clearance via a 510(k) submission (K940039) under the Cardiovascular advisory committee, classified as *Substantially Equivalent* with tracking requirements. This means it was determined to have the same intended use and technological characteristics as a legally marketed predicate device, ensuring compliance with 21 CFR 870.3610 for implantable pacemaker pulse generators. The clearance applies to its use as a polymeric coating in these devices.

Are there any specific storage or handling requirements for Pellethane 75D due to its sterility or regulatory classification?

While the data does not specify exact storage conditions, Pellethane 75D is supplied as sterile, which implies it must be handled in accordance with standard sterile manufacturing protocols for implantable devices. Reusable components like this typically require cleanroom environments, proper packaging integrity, and adherence to FDA’s sterility standards for Class III devices to prevent contamination before use in pacemaker production.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K940039 24 fields · synced Oct 6, 2026