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Device | HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) |
Generic Name | automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant |
HeartSine Technologies, Ltd. |
207 airport road west |
belfast, northern ireland BT3 9 |
|
PMA Number | P160008 |
Date Received | 03/21/2016 |
Decision Date | 01/12/2017 |
Product Code |
MKJ
|
Docket Number | 17M-0229 |
Notice Date | 03/10/2017 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product |
No
|
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 Order |
Approval Order
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Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
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Supplements: |
S015 S001 S002 S005 S012 S003 S014 S010 S007 S006 S008 S004 S009 |