This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the lifepak® 1000 defibrillator, lifepak® 1000 defibrillator lithium-ion rechargeable battery, lifepak® 20 defibrillator/ monitor (refurbished), lifepak® 20e defibrillator/ monitor, lifepak® 15 monitor/defibrillator, and lifepak® lithium-ion rechargeable battery (for use with the lifepak® 15 monitor/defibrillator) these devices are indicated for use as follows:lifepak® 1000 defibrillatorthe defibrillator is to be used in aed mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55 lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with infant/child reduced energy defibrillation electrodes. Lifepak® 20/20e defibrillator/monitors the aed mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ecg rhythm. In aed mode, the lifepak® 20 and lifepak® 20e defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. Lifepak® 15 defibrillator/monitors aed mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patients ecg rhythm. In aed mode, the lifepak® 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
| Device | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Physio-Control. Inc. |
| Date Received | 2016-07-25 |
| Decision Date | 2018-07-02 |
| Notice Date | 2018-08-22 |
| PMA | P160026 |
| Supplement | S |
| Product Code | MKJ |
| Docket Number | 18M-2883 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Physio-Control. Inc. 11811 Willows Road Ne redmond, WA 98052 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |