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.
To implement improvements to the final testing process at the keypad component supplier
| Device | LIFEPAK 15 Monitor/Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Physio-Control. Inc. |
| Date Received | 2021-06-01 |
| Decision Date | 2021-06-22 |
| PMA | P160026 |
| Supplement | S026 |
| 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 | Physio-Control. Inc. 11811 Willows Road Ne redmond, WA 98052 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160026 | Original Filing | |
| S037 | 2022-12-22 | 30-day Notice |
| S036 | 2022-12-06 | 30-day Notice |
| S035 | 2022-10-31 | 30-day Notice |
| S034 | 2022-10-14 | 30-day Notice |
| S033 | 2022-07-22 | 30-day Notice |
| S032 | 2022-07-08 | 30-day Notice |
| S031 | 2022-05-13 | Real-time Process |
| S030 | ||
| S029 | 2021-08-23 | 30-day Notice |
| S028 | ||
| S027 | 2021-06-07 | 30-day Notice |
| S026 | 2021-06-01 | 30-day Notice |
| S025 | 2021-03-29 | 30-day Notice |
| S024 | 2021-02-25 | 30-day Notice |
| S023 | ||
| S022 | ||
| S021 | ||
| S020 | 2020-06-17 | Real-time Process |
| S019 | 2020-05-28 | 30-day Notice |
| S018 | ||
| S017 | ||
| S016 | ||
| S015 | ||
| S014 | 2019-12-12 | Real-time Process |
| S013 | 2019-10-23 | Real-time Process |
| S012 | ||
| S011 | 2019-08-29 | Normal 180 Day Track |
| S010 | 2019-06-07 | Normal 180 Day Track |
| S009 | 2019-04-24 | Real-time Process |
| S008 | 2019-04-22 | 30-day Notice |
| S007 | ||
| S006 | 2019-04-11 | 30-day Notice |
| S005 | 2018-12-28 | 30-day Notice |
| S004 | 2018-12-26 | Real-time Process |
| S003 | 2018-11-09 | 30-day Notice |
| S002 | 2018-10-01 | 30-day Notice |
| S001 | 2018-07-19 | Real-time Process |