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  1. Recently-Approved Devices

TZ Medical Adult and Pediatric Multi-Function Defibrillation Electrodes and Adaptors – P200005

TZ Medical Defibrillation Electrodes and Adaptors monitor a person’s heart rhythm

 

This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.

Product Name: TZ Medical Adult Multi-Function Defibrillation Electrodes and Adapters and TZ Medical Pediatric Multi-Function Defibrillation Electrodes and Adapters
PMA Applicant: TZ Medical, Inc
Address:  17750 SW Upper Boones Ferry Road #150, Portland, OR 97224 USA 
Approval Date: January 9, 2024
Approval Letter: Approval Order

What is it? 

TZ Medical Multi-Function Defibrillation Electrodes and Adaptors monitor the heart’s rhythm and deliver a pacing or electrical shock from a defibrillator (a device that applies an electric charge to the heart to restore a normal heartbeat) to a person with an arrhythmia

 
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