Pulse Generator, Demand, Model 5996
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K780741 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)
This device is an Implantable Pacemaker Pulse-Generator, classified as a Class III medical device under FDA regulations. It delivers timed electrical impulses to regulate heart rhythm in patients with bradycardia or conduction system disorders, ensuring consistent cardiac pacing as specified by its demand functionality.
The Model 5996 is intended for surgical implantation and is designed for single-use within the body. It adheres to FDA 510(k) clearance under the Cardiovascular (CV) Advisory Committee, with a Traditional clearance type and Substantially Equivalent determination. Sterility and MRI safety are not specified in the data, but it is regulated under 21 CFR 870.3610 for implantable pacemaker components.
Frequently asked questions
What is the primary clinical purpose of the Model 5996 Pulse Generator, and how does its demand functionality work?
The Model 5996 Pulse Generator is designed to regulate heart rhythm in patients with bradycardia or conduction system disorders by delivering timed electrical impulses. Its demand functionality ensures pacing only occurs when the patient’s natural heart rate falls below a preset threshold, allowing the device to respond dynamically to the body’s needs while minimizing unnecessary stimulation.
Is this device intended for reuse, or is it meant to remain implanted permanently after a single use?
The Model 5996 is explicitly described as intended for single-use within the body after surgical implantation. Once placed, it is not designed for removal or reuse, aligning with standard practice for implantable pacemaker pulse-generators.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?
The Model 5996 received FDA 510(k) clearance under the Cardiovascular (CV) Advisory Committee, with a Traditional clearance type and a determination of Substantially Equivalent to a predicate device. The review was conducted under 21 CFR 870.3610, which governs implantable pacemaker components.
Are there multiple models or variants of this pulse generator, or is the Model 5996 a standalone product?
The provided data lists the Model 5996 as a specific device, though the associated OpenFDA registration numbers suggest it may share regulatory classifications with related variants or lot-specific identifiers. However, no distinct size, model, or variant specifications are detailed beyond the Model 5996 itself.
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 | K780741 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K780741 24 fields · synced Oct 6, 2026