Powerheart® AED G3 Pro

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P160034

Pre-market Approval Supplement Details

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.

DevicePowerheart® AED G3 Pro
Classification NameAutomated External Defibrillators (non-wearable)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantCardiac Science Corporation
Date Received2016-08-04
Decision Date2018-12-06
PMAP160034
SupplementS
Product CodeMKJ
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Cardiac Science Corporation n7 W22025 Johnson Road Suite 100 suite 100 waukesha, WI 53186

Supplemental Filings

Supplement NumberDateSupplement Type
P160034Original Filing
S002 2020-02-11 30-day Notice
S001 2019-08-01 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00812394023257 P160034 000
00812394023240 P160034 000
00812394023233 P160034 000

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