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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceHeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantGraphic Controls d.b.a. Vermed
400 Exchange Street
Buffalo, NY 14204
PMA NumberP200007
Date Received02/03/2020
Decision Date06/23/2023
Product Code MKJ 
Docket Number 23M-3187
Notice Date 08/04/2023
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the HeartSync Multifunctional Defibrillation Electrodes. These devices are indicated for:For Automatic External Defibrillators: (Compatible Model AEDs: Physio Control: LifePak-15, LifePak-20/20e, LifePak -1000; Zoll Medical: R-Series, X-Series; Cardiac Science: PowerHeart AED G3 Plus, PowerHeart AED G3 Pro).When used with an external defibrillator, these electrode pads are for treating patients in cardiopulmonary arrest who are: 1) Unconscious; 2) Not breathing spontaneously; and 3) Without circulation (without a pulse). The pads are single use and intended to be used in conjunction with an external defibrillator to monitor and deliver defibrillation energy to the patient. The pads are used on patients over 8 years of age or greater than 55 pounds. The pads are intended for short term use (less than 8 hours). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT. For Manual Defibrillators: Manual Defibrillators can be used for monitoring, pacing, cardioversion, as well as defibrillation. When used for defibrillation, these electrode pads are for treating patients in cardiopulmonary arrest who are: 1) Unconscious; 2) Not breathing spontaneously; and 3) Without circulation (without a pulse). The pads are single use and intended to be used in conjunction with an external defibrillator to monitor and deliver defibrillation energy to the patient. The pads are used on patients greater than 10 kg or 22 pounds. The pads are intended for short term use (less than 24 hours).DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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