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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.
DevicePhilips HeartStart FR3 Defibrillator
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
22100 Bothell-Everett Highway
Bothell, WA 98021
PMA NumberP160028
Date Received07/29/2016
Decision Date05/11/2020
Product Code MKJ 
Docket Number 20M-1367
Notice Date 05/08/2020
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Philips HeartStart FR3 Defibrillator. The models 861388 and 861389 are indicated for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and pulseless ventricular tachycardias (VTs). The models 861388 and 861389 are used with the SmartPads III or DP defibrillator pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness;2) Absence of normal breathing; and3) Absence of pulse or signs of circulationThe models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or greater than 8 years old. The models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, do not delay treatment.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S004