Powerheart G3 Pro Automated External Defibrillator

FDA Premarket Approval P160034 S002

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

A supplier change for plastic components for the powerheart g3 pro aed

• Device: Powerheart G3 Pro Automated External Defibrillator
• Generic Name: Automated External Defibrillators (non-wearable)
• Applicant: Zoll Medical Corporation
• Date Received: 2020-02-11
• Decision Date: 2020-03-01
• PMA: P160034
• Supplement: S002
• 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: Zoll Medical Corporation 269 Mill Road chelmsford, MA 01824

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