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: ConMed PadPro Multifunction Electrodes and ConMed PadPro Multifunction Electrode Adapters
PMA Applicant: ConMed Corporation
Address: 525 French Road, Utica, NY 13502 USA
Approval Date: September 26, 2021
Approval Letter: Approval Order
What is it?
ConMed PadPro multifunction electrodes (MFEs) 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.
ConMed PadPro multifunction electrode adapters are a reusable accessory that provide an additional connector type for use with compatible defibrillator brands and models
How does it work?
ConMed PadPro multifunction electrodes are placed on the patient’s chest. The electrode measures electrical signals from their heart and sends the signal to the defibrillator. 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?
ConMed PadPro multifunction electrodes are used by trained medical responders who have compatible defibrillators when a patient is unconscious, has no pulse, and is not breathing normally.
ConMed PadPro multifunction electrode adapters are indicated for use by trained medical professionals in clinical and medical transport environments. They can be used to adapt connection systems on low power defibrillators (up to 360 Joules maximum).
What will it accomplish?
When used with a compatible defibrillator, ConMed PadPro multifunction 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 if the patient is responsive or conscious.