Medtronic Unipolar Poly Pac Lead-Barr Coat Coils
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K913288 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Unipolar Poly Pac Lead-Barr Coat Coils are Permanent Pacemaker Electrodes, designed for implantation in the cardiovascular system. These coils serve as unipolar leads, facilitating electrical signal transmission between a pacemaker and the heart to regulate cardiac rhythm in patients requiring chronic pacing support.
These coils are supplied sterile and intended for single-use implantation. They are classified as Class III devices under FDA regulations and have received FDA 510(k) clearance as substantially equivalent to predicate devices. The coils are intended for use in cardiac electrophysiology procedures and must be handled under sterile conditions prior to implantation, adhering to standard medical device sterilisation and storage protocols.
Frequently asked questions
What is the primary purpose of the Medtronic Unipolar Poly Pac Lead-Barr Coat Coils in clinical practice?
These coils are designed as unipolar leads for permanent pacemaker systems, enabling reliable electrical signal transmission between a pacemaker device and the heart. They are specifically intended for patients who require chronic cardiac pacing support to regulate their heart rhythm.
Are these coils meant for reuse or single-use, and how should they be handled before implantation?
The coils are intended for single-use only and must be handled under sterile conditions prior to implantation. They are supplied sterile, so proper aseptic techniques—including adherence to standard medical device sterilization and storage protocols—are required to maintain integrity before use.
What regulatory pathway was followed for FDA clearance of these coils, and what classification do they fall under?
The coils received FDA 510(k) clearance under the Traditional Review pathway, demonstrating substantial equivalence to predicate devices. They are classified as Class III devices, which is typical for permanent pacemaker electrodes due to their role in life-sustaining or supporting functions.
How are these coils supplied, and what special considerations should be taken for storage?
The coils are supplied sterile and packaged for single-use. Storage should follow manufacturer guidelines to preserve sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or specific storage instructions.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K913288 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K913288 24 fields · synced Oct 6, 2026