Pulse Gene. & Pulse Gene. Lead
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K894494 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 Pulse Gene. & Pulse Gene. Lead is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for use in patients requiring pacing support due to bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function through programmable pacing modes and parameters.
This device is supplied as a reusable, implantable system and is regulated under FDA 510(k) clearance (K894494) with a traditional review pathway in the cardiovascular specialty. Labeling changes reflect updates to its operational specifications, including lead compatibility and programming instructions, while adhering to 21 CFR Part 870.3610 for pacemaker-related devices. No additional sterility or MRI safety classifications are specified in the submitted data.
Frequently asked questions
What types of patients is the Pulse Gene. & Pulse Gene. Lead intended to support with pacing therapy?
The Pulse Gene. & Pulse Gene. Lead is designed for patients who require pacing support due to bradycardia (slow heart rate) or other conduction disorders. It delivers programmable electrical impulses to regulate cardiac rhythm, ensuring consistent and reliable heart function for those with impaired natural conduction systems.
Is the Pulse Gene. & Pulse Gene. Lead system reusable or single-use, and how is it typically supplied?
The Pulse Gene. & Pulse Gene. Lead is a reusable, implantable system, meaning it is intended for long-term use within a patient after surgical implantation. It is not a single-use device, and the labeling changes reflect updates to its operational specifications, including lead compatibility and programming instructions, rather than changes to its reuse status.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for clinicians?
The Pulse Gene. & Pulse Gene. Lead received FDA clearance under the 510(k) pathway (K894494), specifically through a traditional review in the cardiovascular specialty (advisory committee: CV). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator.
Are there any specific storage requirements or considerations for the Pulse Gene. & Pulse Gene. Lead system?
The provided data does not specify explicit storage requirements (e.g., temperature, humidity, or shelf-life) for the Pulse Gene. & Pulse Gene. Lead system. However, as an implantable medical device, it should be handled according to standard sterile or clean-room protocols before implantation, though no sterility classification (e.g., sterile or non-sterile) is mentioned in the labeling changes. Always follow manufacturer guidelines for pre-procedural preparation.
How does the labeling update for this device affect its compatibility with existing leads or programming systems?
The labeling changes for the Pulse Gene. & Pulse Gene. Lead focus on operational specifications, including lead compatibility and programming instructions, to ensure the device functions correctly with approved leads and software. Clinicians should verify compatibility with their specific lead models and programming tools as outlined in the updated labeling to avoid technical issues during use.
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: Labeling Changes to Pulse Gene. & Pulse Gene. Lead (K894494) — Fda 510 ..., K894494 FDA 510(k) - LABELING CHANGES TO PULSE GENE. & PULSE..., PDF K894494 - Labeling Changes to Pulse Gene. & Pulse Gene. Lead, Drug Safety-related Labeling Changes | FDA, PDF Summary Memo P980023/S060, P950037/S138, and P070008/S054 Various Lead ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894494 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, GmbH & Co.
Sources (1)
- FDA 510(k) K894494 24 fields · synced Sep 18, 2026