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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceHeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
Classification Nameover-the-counter automated external defibrillator
Generic Nameover-the-counter automated external defibrillator
Regulation Number870.5310
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
22100 bothell -everett hwy
bothell, WA 98021
PMA NumberP160029
Date Received07/29/2016
Decision Date06/06/2019
Product Code
NSA[ Registered Establishments with NSA ]
Docket Number 19M-2782
Notice Date 07/02/2019
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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