Approval for the powerheart® aed g3, powerheart® aed g3 plus, and the powerheart® aed g5. The powerheart® aed g3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse. When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the intellisense defibrillation pad pediatric. The therapy should not be delayed to determine the patient's exact age or weight. The powerheart® aed g3 is intended to be used by personnel who have been trained in its operation. The powerheart® aed g3 plus is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse. When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the intellisense defibrillation pad pediatric. The therapy should not be delayed to determine the patient's exact age or weight. The powerheart® aed g3 plus is intended to be used by personnel who have been trained in its operation. The powerheart® aed g5 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse. When a patient is a child up to 8 years of age, or up to 25kg (55 lbs. ), the aed should be used with the intellisense defibrillation pad pediatric. The therapy should not be delayed to determine the patient's exact age or weight. The g5 automated external defibrillator (aed) is intended to be used by persons who have been trained in its operation. When used with the optional intellisense defibrillation pad icpr, the device offers cpr performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The intellisense defibrillation pad icpr is indicated-for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 lbs. ).
| Device | Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION |
| Date Received | 2016-08-03 |
| Decision Date | 2018-12-07 |
| PMA | P160033 |
| Supplement | S |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIAC SCIENCE CORPORATION n7 W22025 Johnson Dr suite 100 waukesha, WI 53186 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160033 | | Original Filing |
| S008 |
2021-06-04 |
30-day Notice |
| S007 | | |
| S006 | | |
| S005 |
2021-01-08 |
30-day Notice |
| S004 |
2019-08-01 |
30-day Notice |
| S003 | | |
| S002 |
2019-04-29 |
Normal 180 Day Track |
| S001 |
2018-12-17 |
Real-time Process |
NIH GUDID Devices