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).
| Device | HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | HeartSine Technologies LLC |
| Date Received | 2016-03-21 |
| Decision Date | 2017-01-12 |
| Notice Date | 2017-03-10 |
| PMA | P160008 |
| Supplement | S |
| Product Code | MKJ |
| Docket Number | 17M-0229 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HeartSine Technologies LLC 121 Friends Lane suite 400 newton, PA 18940 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160008 | | Original Filing |
| S021 |
2022-11-01 |
30-day Notice |
| S020 |
2022-08-29 |
Real-time Process |
| S019 |
2022-03-28 |
Real-time Process |
| S018 | | |
| S017 | | |
| S016 |
2021-05-20 |
30-day Notice |
| S015 |
2020-10-28 |
30-day Notice |
| S014 |
2020-09-24 |
30-day Notice |
| S013 | | |
| S012 |
2020-06-22 |
30-day Notice |
| S011 | | |
| S010 |
2020-02-13 |
30-day Notice |
| S009 | | |
| S008 |
2019-12-13 |
30-day Notice |
| S007 |
2019-10-31 |
30-day Notice |
| S006 |
2019-06-03 |
30-day Notice |
| S005 |
2019-02-01 |
30-day Notice |
| S004 |
2018-11-23 |
Real-time Process |
| S003 |
2018-11-21 |
30-day Notice |
| S002 |
2018-10-02 |
30-day Notice |
| S001 |
2018-09-11 |
30-day Notice |
NIH GUDID Devices