Modifications to the soldering method used for seven (7) specific plated through-hole (pth) components from selective soldering to manual soldering and adding manual cleaning of the test point pads of the printed circuit board assembly (pcba)
| Device | HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | HeartSine Technologies, Ltd. |
| Date Received | 2020-09-24 |
| Decision Date | 2020-10-22 |
| PMA | P160008 |
| Supplement | S014 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HeartSine Technologies, Ltd. 203 Airport Road West belfast, Northern Ireland BT3 9 |
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