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.
Approval for modifications to the non-invasive blood pressure (nibp) module, minimedi co2 module and co2 filterline recognition safe guard assembly (frs) components of the lifepak 15 monitor/defibrillator.
| Device | LIFEPAK 15 Monitor/Defibrillator |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Physio-Control. Inc. |
| Date Received | 2018-07-19 |
| Decision Date | 2018-08-06 |
| PMA | P160026 |
| Supplement | S001 |
| 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 | 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 |