Powerheart® G3 Pro AED

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P160034 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Update to the smart packing software to automate a verification step.

• Device: Powerheart® G3 Pro AED
• Classification Name: Automated External Defibrillators (non-wearable)
• Generic Name: Automated External Defibrillators (non-wearable)
• Applicant: Cardiac Science Corporation
• Date Received: 2019-08-01
• Decision Date: 2019-08-20
• PMA: P160034
• Supplement: S001
• Product Code: MKJ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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

Device ID	PMA	Supp
00812394023257	P160034	000
00812394023240	P160034	000
00812394023233	P160034	000