EnerTrax Model 7100E Implantable Pacemaker Pulse-Generator
510(k) K822297
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822297 | Date4 Oct 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Enertrax Model 7100E
- 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 EnerTrax Model 7100E is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. Classified as a Class III device under FDA regulations, it is intended for patients requiring chronic cardiac pacing to manage bradycardia or other conduction disorders.
This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings. It is regulated under FDA 510(k) clearance (K822297) and falls under the medical specialty of cardiovascular care. The device is non-MRI-compatible and must be handled and stored according to manufacturer instructions to maintain sterility and functionality.
Other devices from Medtronic Vascular, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical purpose of the EnerTrax Model 7100E pacemaker, and who is it intended for?
The EnerTrax Model 7100E is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring chronic cardiac pacing. It is intended for managing bradycardia or conduction disorders, ensuring consistent heart function in individuals whose natural pacemaker is insufficient.
Is the EnerTrax Model 7100E meant for repeated use, or is it a single-use implantable device?
The EnerTrax Model 7100E is supplied sterile and intended for single-use implantation only. After implantation, it is not designed for removal or reuse, and its functionality is meant to be permanent for the patient’s chronic pacing needs.
Can this device be used in patients who require MRI scans, or does it have any MRI-related restrictions?
The EnerTrax Model 7100E is explicitly non-MRI-compatible, meaning it should not be used in patients who require MRI imaging. The device must be handled and stored according to manufacturer instructions to avoid exposure to MRI environments, as this could compromise its safety and performance.
How should the EnerTrax Model 7100E be stored to ensure sterility and functionality before implantation?
The device must be stored following the manufacturer’s guidelines to maintain sterility and functionality. Since it is supplied sterile and intended for single-use, it should remain in its original packaging until immediately before implantation, protected from contamination and environmental damage.
What regulatory pathway was followed for FDA clearance of the EnerTrax Model 7100E, and which advisory committee was involved?
The EnerTrax Model 7100E received FDA clearance through a Traditional 510(k) pathway (K822297) and was reviewed by the Cardiovascular (CV) Advisory Committee. The device was determined to be Substantially Equivalent (SESE) to a legally marketed predicate, ensuring compliance with FDA Class III requirements for implantable pacemakers.