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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DevicePowerheart® AED G3 Pro
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZoll Medical Corporation
269 Mill Road
Chelmsford, MA 01824
PMA NumberP160034
Date Received08/04/2016
Decision Date12/06/2018
Product Code MKJ 
Docket Number 18M-4672
Notice Date 12/11/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Powerheart® AED G3 Pro.The Powerheart® AED G3 Pro is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse.When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.The Powerheart® AED G3 Pro is intended to be used by personnel who have been trained in its operation.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002