Unipolar Spectrax Impl. Pulse Generat.
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K811350 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 Unipolar Spectrax Implantable Pulse Generator is classified as an Implantable Pacemaker Pulse-Generator (Product Code DXY), a Class III medical device designed to regulate heart rhythm by delivering electrical impulses. It is intended for use in patients requiring cardiac pacing to maintain proper heart function, particularly those with bradycardia or other conduction disorders.
This device is supplied as a reusable, implantable component within a cardiovascular setting and is regulated under FDA 510(k) clearance (K811350) with a decision date of July 1, 1981. It falls under the regulatory category 870.3610 and is intended for use in procedures reviewed by the Cardiovascular Advisory Committee. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the primary clinical purpose of the Unipolar Spectrax Implantable Pulse Generator and who would benefit from it?
The Unipolar Spectrax Implantable Pulse Generator is designed to regulate heart rhythm by delivering electrical impulses, specifically for patients with bradycardia or conduction disorders requiring cardiac pacing. It helps maintain proper heart function in individuals whose natural pacing is insufficient, ensuring consistent and effective heart contractions.
Is the Unipolar Spectrax Implantable Pulse Generator intended for single-use or can it be reused?
The Unipolar Spectrax Implantable Pulse Generator is explicitly described as a reusable device, intended for implantation within a cardiovascular setting. It is not designed for single-use and is meant to remain implanted in the patient long-term.
What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed its submission?
The Unipolar Spectrax Implantable Pulse Generator received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent (SESE). Its submission was reviewed by the Cardiovascular Advisory Committee (CV), which oversees procedures related to cardiovascular devices, including pacemakers.
Are there any specific storage instructions or sterility considerations mentioned for this device?
The available data does not provide explicit details regarding sterility or storage instructions for the Unipolar Spectrax Implantable Pulse Generator. Since it is an implantable device, proper handling and sterile techniques would be critical during implantation, though these specifics are not outlined in the provided information.
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: UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. - Innolitics, Medtronic Vascular Unipolar Spectrax Impl. Pulse Generat, K812153 FDA 510(k) - MEDTRONIC SPECTRAX | Medtronic Vascular
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811350 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K811350 24 fields · synced Oct 6, 2026