Pulse Generator, Pacemaker
by Vitatron Medical BV 510(k)
Active
510(k) K781168
Overview
This device 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 Pulse Generator, Pacemaker is supplied as a sterile, single-use implantable device and must be implanted surgically under sterile conditions. It is regulated under FDA 510(k) clearance (K781168) and falls under product code DXY, with no explicit MRI safety labeling provided. Storage and handling follow standard sterile implantable device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781168 | Date31 Aug 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Generator, Pulse, Pacemaker
- 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
Other devices from Vitatron Medical BV
Questions
What types of heart conditions is this pacemaker designed to treat, and how does it work?
This device is specifically designed to treat patients with bradycardia or conduction disorders that require chronic cardiac pacing. It works by delivering regulated electrical impulses to the heart muscle, helping to maintain a normal heart rhythm when the natural pacemaker of the heart is not functioning properly.
Is this pacemaker meant for repeated use, or is it intended to be implanted once and then discarded?
The device is supplied as a sterile, single-use implantable pacemaker pulse-generator. Once implanted surgically under sterile conditions, it is not intended for reuse or removal. It is meant to remain in place as a permanent solution for the patient’s pacing needs.
What storage and handling precautions should be taken for this device before implantation?
Since this is a sterile, implantable device, it must be stored and handled according to standard protocols for sterile implantable medical devices. This includes maintaining proper temperature, humidity, and contamination control to ensure sterility until the time of surgical implantation.
Are there any specific safety considerations regarding MRI use with this pacemaker?
The device does not come with explicit MRI safety labeling, meaning it is not recommended for use in MRI environments. Patients with this pacemaker should avoid MRI scans unless specifically cleared by their healthcare provider, as untested exposure could pose risks.