Approval for the lifepak cr® plus defibrillator, lifepak express® defibrillator, and charge-pak® battery charger. The lifepak cr plus and lifepak express defibrillators are indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/aed, advanced life support or a physician-authorized emergency medical response training program. The defibrillators may be used with quik-pak defibrillations pads only on adults and children who are 8 years old or more, or who weigh more than 25kg (55lbs). The defibrillators may be used on children who are less than 8 years old or weigh less than 25k (55lbs) with infant/child reduced energy defibrillation electrodes. The defibrillators may be used with the charge-pak battery charger.
| Device | LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Physio-Control. Inc. |
| Date Received | 2016-04-27 |
| Decision Date | 2017-12-21 |
| Notice Date | 2018-03-20 |
| PMA | P160012 |
| Supplement | S |
| Product Code | MKJ |
| Docket Number | 17M-6983 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Physio-Control. Inc. 11811 Willows Rd. Ne redmond, WA 98052 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
NIH GUDID Devices