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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® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
ZOLL Medical Corporation
269 mill road
chelmsford, MA 01824
PMA NumberP160033
Date Received08/03/2016
Decision Date12/07/2018
Product Code MKJ 
Docket Number 18M-4675
Notice Date 10/21/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the Powerheart® AED G3, Powerheart® AED G3 Plus, and the Powerheart® AED G5.The Powerheart® AED G3 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 Intellisense Defibrillation Pad Pediatric. The therapy should not be delayed to determine the patient's exact age or weight.The Powerheart® AED G3 is intended to be used by personnel who have been trained in its operation.The Powerheart® AED G3 Plus 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 Intellisense Defibrillation Pad Pediatric. The therapy should not be delayed to determine the patient's exact age or weight.The Powerheart® AED G3 Plus is intended to be used by personnel who have been trained in its operation.The Powerheart® AED G5 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 a patient is a child up to 8 years of age, or up to 25kg (55 lbs.), the AED should be used with the Intellisense Defibrillation Pad Pediatric. The therapy should not be delayed to determine the patient's exact age or weight.The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation.When used with the optional Intellisense Defibrillation Pad ICPR, the device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The Intellisense Defibrillation Pad ICPR is indicated-for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 lbs.).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  S001 S002 S004 S005 
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