This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | HeartSine’s 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.207 Airport Road Westbelfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS021 Date Received11/01/2022 Decision Date11/23/2022 Product Code MKJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-01 |
| Decision Date | 2022-11-23 |
| PMA | P160008 |
| Supplement | S021 |
| 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. 207 Airport Road West belfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS021 Date Received11/01/2022 Decision Date11/23/2022 Product Code MKJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement for The Implementation Of A Manufacturing Process Change To Detect Faulty Membrane LED Components In The Testing Of A Printed Circuit Board Assembly |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05060167120695 | P160008 | 004 |
| 05060167129773 | P160008 | 004 |
| 05060167129735 | P160008 | 004 |
| 05060167129711 | P160008 | 004 |
| 05060167128066 | P160008 | 004 |
| 05060167120916 | P160008 | 004 |
| 05060167120893 | P160008 | 004 |
| 05060167120886 | P160008 | 004 |
| 05060167120701 | P160008 | 004 |
| 05060167120671 | P160008 | 004 |
| 05060167120688 | P160008 | 004 |
| 05060167120718 | P160008 | 004 |
| 05060167128080 | P160008 | 004 |
| 05060167128042 | P160008 | 004 |
| 05060167120909 | P160008 | 004 |
| 05060167120862 | P160008 | 004 |
| 05060167120855 | P160008 | 004 |
| 05060167120725 | P160008 | 004 |
| M727PADPAK01 | P160008 | 008 |
| M727PADPAK02 | P160008 | 008 |
| 05060167124488 | P160008 | 008 |