Approval for the powerheart® aed g3 pro. The powerheart® aed g3 pro 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 pediatric defibrillation pads. The therapy should not be delayed to determine the patient's exact age or weight. The powerheart® aed g3 pro is intended to be used by personnel who have been trained in its operation.
| Device | Powerheart® AED G3 Pro |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Cardiac Science Corporation |
| Date Received | 2016-08-04 |
| Decision Date | 2018-12-06 |
| PMA | P160034 |
| Supplement | S |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cardiac Science Corporation n7 W22025 Johnson Road Suite 100 suite 100 waukesha, WI 53186 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160034 | | Original Filing |
| S002 |
2020-02-11 |
30-day Notice |
| S001 |
2019-08-01 |
30-day Notice |
NIH GUDID Devices