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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.
 
DeviceHeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantHeartSine Technologies, Ltd.
207 Airport Road West
Belfast, Northern Ireland BT3 9
PMA NumberP160008
Date Received03/21/2016
Decision Date01/12/2017
Product Code MKJ 
Docket Number 17M-0229
Notice Date 03/10/2017
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the HeartSine samaritan® PAD 350P (SAM 350P), PAD 360P (SAM 360P), and PAD 450P (SAM 450P) public access automated external defibrillators and battery/electrode accessories. These AEDs are indicated for use on victims of cardiac arrest who are exhibiting the following signs: 1) Unconscious; 2) Not breathing; and 3) Without circulation (without a pulse)The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pak (Pad-Pak-02).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 S026 
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