This is a brief overview of information related to 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 FDA’s approval.
Product Name: Kendall Multifunction Defibrillation Electrodes, MEDI-TRACE™ Cadence Defibrillation Electrodes, Physio-Control/Stryker QUIK-COMBO Pacing/Defibrillation/ECG Electrodes
PMA Applicant: Cardinal Health
Address: 777 West Street Mansfield, MA 02048
Approval Date: August 7, 2020
Approval Letter: Approval Order
What is it? Kendall Multifunction Defibrillation Electrodes, MEDI-TRACE Cadence Defibrillation Electrodes, Physio-Control/Stryker QUIK-COMBO Pacing/Defibrillation/ECG Electrodes (“Multifunction Defibrillation Electrodes”), are a set of sensors that are attached to a compatible defibrillator and then placed on a person experiencing cardiac arrest to detect and help correct irregular heartbeats.
How does it work? Kendall Multifunction Defibrillation Electrodes are a pair of disposable electrode pads, either provided with a wire and connector or a post. One side of each electrode sticks to a person’s chest to measure electrical signals from their heart. If an irregular heartbeat is detected, the attached defibrillator delivers an electric pulse or shock to restore the heart’s normal beating.
When is it used? Kendall Multifunction Defibrillation Electrodes are used in clinical and out of hospital settings along with a compatible defibrillator to help save the life of a person experiencing an abnormal heartbeat due to sudden cardiac arrest.
What will it accomplish? When used with a compatible defibrillator, Kendall Multi-function Defibrillation Electrodes can reduce the time a person is in cardiac arrest and increase the chance of survival.
When should it not be used? The multifunction electrodes should not be used on a person who is conscious or responsive.
Additional information (including warnings, precautions, and adverse events):