Centurion Implantable Pacemaker Pulse-Generator
by Johnson & Johnson Professionals, Inc. 510(k)
Active
510(k) K770419
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770419 | Date5 Apr 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Centurion
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Centurion is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart when necessary. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing, providing programmable pacing rates and modes to support sustained cardiac function.
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 (K770419) and falls under regulation number 870.3610, with a device classification of Class III. Multiple registration numbers (e.g., 2017865, 3005334138) correspond to its various model variants, all adhering to OpenFDA’s Implantable Pacemaker Pulse-Generator nomenclature.
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Questions
AI-generated answers, 18 Sep 2026
What types of heart conditions is the Centurion pacemaker designed to treat, and how does it work?
The Centurion is designed for patients with bradycardia or conduction disorders requiring chronic cardiac pacing. It regulates heart rhythm by delivering programmable electrical impulses to the heart when needed, ensuring sustained cardiac function through adjustable pacing rates and modes.
Is the Centurion pacemaker intended for single-use or can it be reused after implantation?
The Centurion is supplied sterile and intended for single-use implantation. While it may be reprogrammable post-implantation, it is not designed for reuse after removal or replacement.
How many model variants of the Centurion pacemaker exist, and how can I identify the correct registration number for my needs?
The Centurion has multiple model variants, each with distinct registration numbers such as 2017865, 3005334138, and others listed in the OpenFDA database. These variants are all classified under the Implantable Pacemaker Pulse-Generator category, so verifying the specific registration number with your supplier or manufacturer ensures compatibility with your clinical requirements.
What regulatory pathway was followed for the Centurion pacemaker, and which advisory committee was involved?
The Centurion underwent a traditional 510(k) clearance process through the FDA, with a decision described as 'Substantially Equivalent' (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under regulation number 870.3610.
Does the Centurion pacemaker require any special storage conditions before implantation?
Since the Centurion is supplied sterile and intended for single-use, it should be stored according to the manufacturer’s instructions to maintain sterility until implantation. Proper packaging and environmental controls (e.g., temperature, humidity) are critical to preserving its integrity before use.