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

DevicePowerheart G3 Pro Automated External Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantZoll Medical Corporation
Date Received2020-02-11
Decision Date2020-03-01
PMAP160034
SupplementS002
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Zoll Medical Corporation 269 Mill Road chelmsford, MA 01824

Supplemental Filings

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

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