Medtronic Models 5966/5967 Implantable Pacemaker Pulse-Generator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K800069 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
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Models 5966/5967 Implantable Pacemaker Pulse-Generator is a Class III medical device classified under product code DXY. It functions as an implantable device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle, ensuring proper pacing in patients with bradycardia or other conduction disorders.
These pulse-generators are intended for surgical implantation and are regulated under FDA 510(k) clearance (K800069) with a decision of Substantially Equivalent (SESE). Supplied sterile and intended for single-use, they are approved for use in cardiovascular procedures and comply with regulation 870.3610. Each model number corresponds to a specific variant, ensuring precise identification for clinical and regulatory purposes.
Frequently asked questions
What specific heart conditions is this device designed to address, and how does it work?
This device, the Medtronic Models 5966/5967 Implantable Pacemaker Pulse-Generator, is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper pacing to maintain a healthy heart rhythm. The pulse-generator is surgically implanted and continuously monitors and stimulates the heart as needed.
Are these pulse-generators reusable, or are they intended for single-use only?
The Medtronic Models 5966/5967 Implantable Pacemaker Pulse-Generators are supplied sterile and explicitly intended for single-use only. This ensures patient safety and sterility, as reusing implanted medical devices is not recommended due to infection risks and potential device degradation.
How do I identify the correct model for my clinical needs, and are there multiple variants available?
Each model number (e.g., 5966, 5967) corresponds to a specific variant of the pulse-generator, allowing precise selection based on clinical requirements. The exact specifications or differences between models are not detailed in the provided data, but the distinct model numbers ensure proper identification for regulatory and procedural purposes. Always refer to Medtronic’s clinical documentation for model-specific features.
What regulatory pathway was followed for FDA clearance, and how does this affect its use?
The device underwent FDA 510(k) clearance (K800069) under the Cardiovascular (CV) Advisory Committee, with a decision of Substantially Equivalent (SESE). This means the device was deemed comparable to a legally marketed predicate device, ensuring compliance with regulation 870.3610 for implantable pacemaker pulse-generators. Clinicians can rely on this clearance for use in cardiovascular procedures, though local regulations and institutional protocols should always be followed.
How should these devices be stored before implantation, and what precautions should be taken?
Since these pulse-generators are sterile upon supply, they must be stored in their original packaging to maintain sterility until use. Storage conditions typically include protection from moisture, extreme temperatures, and physical damage. Always follow Medtronic’s provided storage instructions to preserve functionality and ensure patient safety during implantation.
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. Sources consulted: K800069 FDA 510 (k) - MEDTRONIC MODELS 5966/5967, MEDTRONIC MODELS 5966/5967, ETC. (K800069) — FDA 510 (k) | Innolitics, Medtronic Models 5966/5967, Etc. 510(k) K800069 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K800069 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K800069 24 fields · synced Oct 6, 2026