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DiamondTemp RF Generator

by Medtronic, Inc.

PMA P200028

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

PMA P200028↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200028 Date28 Jan 2021ApprovedStatusActive

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1320-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1318-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1317-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1322-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1319-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1321-2021 FDA Class II initiated 22 Feb 2021

    It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
DiamondTemp Radiofrequency Generator
Trade Name
DiamondTemp Ablation System
Generic Name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
PMA Number
FDA Product Code
OAE
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DiamondTemp RF Generator is a Class III percutaneous cardiac ablation device designed for electrophysiological mapping, stimulation, and recording during cardiac procedures. It delivers radiofrequency energy in conjunction with the DiamondTemp Catheter for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

This device is intended for use in a clinical setting with compatible mapping systems and accessories, including the DiamondTemp Catheter, cables, irrigation pump, and tubing. It is not single-use and requires proper sterilisation and maintenance as specified by the manufacturer. The device holds an FDA PMA approval (P200028) and is regulated under the OpenFDA product code OAE for cardiac ablation applications.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DiamondTemp Radiofrequency Generator primarily used for in clinical settings?

    The DiamondTemp Radiofrequency Generator is designed for electrophysiological mapping, stimulation, and recording during cardiac procedures. It delivers radiofrequency energy in conjunction with the DiamondTemp Catheter to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. It requires compatible mapping systems and accessories like the DiamondTemp Catheter, cables, irrigation pump, and tubing for full functionality.

  • Is the DiamondTemp Radiofrequency Generator a single-use device, or can it be reused after proper sterilization?

    The DiamondTemp Radiofrequency Generator is not a single-use device. It requires proper sterilization and maintenance as specified by the manufacturer to ensure safe and effective reuse in clinical settings. Always follow Medtronic’s guidelines for cleaning and sterilization to maintain device integrity and performance.

  • What regulatory approval does the DiamondTemp Radiofrequency Generator hold, and how does it relate to its use?

    The DiamondTemp Radiofrequency Generator holds an FDA Premarket Approval (PMA) under the number P200028. This approval specifically authorizes its use in conjunction with the DiamondTemp Catheter for electrophysiological mapping, stimulation, recording, and ablation of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The device is classified as Class III and regulated under the OpenFDA product code OAE for cardiac ablation applications.

  • What accessories are required for the DiamondTemp Radiofrequency Generator to function effectively during a cardiac procedure?

    The DiamondTemp Radiofrequency Generator requires several compatible accessories to operate effectively, including the DiamondTemp Catheter, DiamondTemp Catheter-to-RF Generator Cable, DiamondTemp GenConnect Cable, DiamondTemp EGM Cable, DiamondTemp Irrigation Pump, and DiamondTemp Irrigation Tubing Set. These components work together to enable electrophysiological mapping, stimulation, recording, and ablation during atrial fibrillation treatment procedures.

  • How does the DiamondTemp Radiofrequency Generator integrate with existing clinical workflows, particularly in terms of mapping systems?

    The DiamondTemp Radiofrequency Generator is designed to work with compatible mapping systems used in electrophysiology labs. It delivers radiofrequency energy in tandem with the DiamondTemp Catheter and other specified accessories, ensuring seamless integration with existing workflows for electrophysiological mapping, stimulation, and ablation. This compatibility allows clinicians to leverage their current systems while utilizing the DiamondTemp system for targeted atrial fibrillation treatment.