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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.
 
DeviceHeartStart FRx Defibrillator
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
Philips Medical Systems
22100 bothell everett hwy
bothell, WA 98021
PMA NumberP180028
Date Received08/03/2018
Decision Date05/11/2020
Product Code MKJ 
Docket Number 20M-1368
Notice Date 05/12/2020
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
RecallsCDRH Recalls
Approval Order Statement 
Approval for the HeartStart FRx Defibrillator (Model 861304). The device is indicated for use on potential victims of sudden cardiac arrest (SCA) with the following symptoms:1) Unconsciousness; and2) Absence of normal breathingThe HeartStart FRx (Model 861304) is indicated for adults over 55 pounds (25 kg). The Model 861304 is also indicated for infants and children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key (Model 989803139311). If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, proceed using adult treatment without the infant/child key.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 
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