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: HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
PMA Applicant: Graphic Controls dba Nissha Medical Technologies/ Vermed/ Biomedical Innovations
Address: 400 Exchange Street, Buffalo, NY 14204
Approval Date: June 23, 2023
Approval Letter: Approval Order
What is it?
HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (HeartSync Defibrillation Electrodes) are disposable electrode pads, or sensors, that can deliver an electrical shock from a defibrillator to someone whose heart has stopped beating (cardiac arrest). Together with a compatible defibrillator, these pads help detect and correct irregular heartbeats.
How does it work?
The HeartSync Defibrillation Electrodes are packaged with wires (leads) inside or outside the package and a connector to match a specific defibrillator. One side of each electrode sticks to the person’s chest to measure electrical signals from their heart. If an irregular heartbeat is detected, the defibrillator can deliver an electric pulse or shock through the pads to restore the heart’s normal rhythm.
When is it used?
HeartSync Defibrillation Electrodes are indicated for use with compatible defibrillators by trained emergency responders. They can be used to treat abnormal heart rhythms including ventricular fibrillation, the most common cause of sudden cardiac arrest. Different electrode models are indicated for use with either automated external defibrillators (AEDs) or manual defibrillators.
What will it accomplish?
When used with a compatible defibrillator, HeartSync Defibrillation Electrodes can reduce the time a person is in cardiac arrest and therefore increase the chance of survival.
When should it not be used?
HeartSync Defibrillation Electrodes should not be used if the person is awake (conscious) and responsive.