Model 100 Cardiac Pacemaker
by Pacesetter Systems 510(k)
Active
510(k) K760757
Overview
The Model 100 Cardiac Pacemaker 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.
This device is implanted subcutaneously in a sterile surgical setting and is intended for single-use implantation. It is classified under FDA regulation number 870.3610 and received a Traditional 510(k) clearance (K760757) in 1976. The device is non-rechargeable and does not require external power sources post-implantation. No MRI safety information is specified in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760757 | Date11 Nov 1976 | 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- Withdrawn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
- 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 Pacesetter Systems
Questions
What types of heart conditions is the Model 100 Cardiac Pacemaker designed to treat, and how does it work?
The Model 100 Cardiac Pacemaker is designed to treat patients with bradycardia (slow heart rate) or other conduction disorders that require chronic cardiac pacing. It works by delivering controlled electrical impulses to the heart muscle, helping to regulate abnormal heart rhythms and maintain a consistent heartbeat when the heart’s natural pacemaker isn’t functioning properly.
Is the Model 100 Cardiac Pacemaker intended for reuse, or is it meant to be implanted once and then discarded?
The Model 100 Cardiac Pacemaker is intended for single-use implantation only. Once implanted subcutaneously in a sterile surgical setting, it is not designed to be removed or reused. This aligns with its classification as a non-rechargeable device without external power requirements post-implantation.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Model 100 Cardiac Pacemaker received a Traditional 510(k) clearance (K760757) under FDA regulation number 870.3610, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it was as safe and effective as a previously approved device, allowing it to be legally marketed for its intended use in the U.S. without additional clinical trials.
How is the Model 100 Cardiac Pacemaker supplied, and what should be considered during storage?
The Model 100 Cardiac Pacemaker is supplied as a sterile, single-use implantable device, intended for surgical implantation in a controlled environment. Since it is non-rechargeable and designed for long-term use, storage should follow manufacturer guidelines to preserve its integrity—typically in a clean, dry place away from extreme temperatures or moisture until implantation.
Are there any specific considerations regarding MRI compatibility for this device?
The provided data does not specify MRI safety information for the Model 100 Cardiac Pacemaker. Clinicians should consult the manufacturer’s instructions or updated labeling before exposing patients with this device to MRI procedures, as pacemakers can interact with magnetic fields and pose risks.