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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 OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
Generic NameOver-the-counter automated external defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
22100 BOTHELL -EVERETT HWY
BOTHELL, WA 98021
PMA NumberP160029
Date Received07/29/2016
Decision Date06/06/2019
Product Codes MKJ NSA 
Docket Number 19M-2782
Notice Date 07/02/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A). The HeartStart OnSite Defibrillator (M5066A) is indicated for use on potential victims of sudden cardiac arrest with the following symptoms:1) Unconsciousness; and 2) Absence of normal breathing.The HeartStart OnSite (Model M5066A) is indicated for adults over 55 pounds (25 kg). It is also indicated for infants and children under 55 lbs (25 kg) or 8 years old when used with the optional infant/child SMART pads. If Infant/Child SMART pads are not available, or you are uncertain of the childs age or weight, proceed with treatment using adult SMART pads.The HeartStart Home Defibrillator (M5068A) is indicated for use on potential victims of cardiac arrest with the following symptoms: 1) Unconsciousness; and 2) Absence of normal breathing. The HeartStart Home (M5068A) is indicated for adults over 55 pounds (25 kg). They are also indicated for infants and children under 55 lbs (25 kg) or 8 years old when used with the optional infant/child SMART pads. If Infant/Child SMART pads are not available, or you are uncertain of the childs age or weight, proceed with treatment using adult SMART pads.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
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