Medtronic Model 8436 Pacemaker Pulse Generator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K844957 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 Model 8436 Pacemaker Pulse Generator is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing. The device is implanted subcutaneously and connected to one or more leads to stimulate the heart as needed.
This device is supplied sterile and intended for single-use implantation, though it may be reprogrammable post-implantation. It is regulated under FDA 510(k) clearance (K844957) and falls under the Cardiovascular advisory committee classification. The device is classified as Device Class 3 under regulation number 870.3610, reflecting its high-risk, life-sustaining nature. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What clinical conditions is the Medtronic Model 8436 Pacemaker Pulse Generator designed to address?
The Medtronic Model 8436 Pacemaker Pulse Generator is specifically designed for patients with bradycardia (slow heart rate) or other conduction disorders that require chronic cardiac pacing. It delivers electrical impulses to regulate abnormal heart rhythms by stimulating the heart muscle as needed, ensuring proper cardiac function for patients dependent on pacing therapy.
Is the Medtronic Model 8436 Pacemaker Pulse Generator intended for single-use or reusable implantation?
The device is sterile upon supply and intended for single-use implantation. While it may be reprogrammable post-implantation, it is not designed for reuse after initial use, adhering to standard sterile medical device protocols for implantable devices.
How is the Medtronic Model 8436 Pacemaker Pulse Generator regulated, and what does that mean for purchasing or clinical use?
The device holds FDA 510(k) clearance (K844957) under the Cardiovascular advisory committee classification, classified as a Class III device (regulation number 870.3610) due to its high-risk, life-sustaining nature. This means it undergoes rigorous review for safety and effectiveness, ensuring compliance with strict manufacturing, labeling, and post-market surveillance requirements for implantable cardiac devices.
What storage and handling precautions must be followed for the Medtronic Model 8436 Pacemaker Pulse Generator?
Since the device is sterile and intended for single-use implantation, storage must comply with sterile medical device protocols to maintain integrity until use. This includes proper packaging, temperature control, and protection from contamination, as outlined in Medtronic’s instructions for handling implantable pulse generators.
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: Medtronic Manuals: Home, Electrosurgical Generators & Monitors | Medtronic, Medtronic Vascular Classix Models 8436/8437/8438 - allmed.wiki, Peripheral vascular health products - Medtronic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K844957 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K844957 24 fields · synced Oct 6, 2026