Identifiers
- 510(k) Number
- K790261 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 Tempron is a Permanent Pacemaker Electrode, designed for implantation within the cardiovascular system to facilitate cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function.
This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings such as hospitals or cardiac care units. It adheres to FDA 510(k) clearance under the classification of Class III (DTB product code) and is regulated under the U.S. regulation number 870.3680. Multiple model references are available, ensuring compatibility with various pacemaker systems.
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 | K790261 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K790261 24 fields · synced Oct 6, 2026