Approval for minor changes including the addition of emc suppression circuitry, pcba and membrane standardization, related manufacturing changes, and labeling updates.
| Device | HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | HeartSine Technologies LLC |
| Date Received | 2018-11-23 |
| Decision Date | 2019-02-19 |
| PMA | P160008 |
| Supplement | S004 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HeartSine Technologies LLC 121 Friends Lane suite 400 newton, PA 18940 |
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