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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantAED Battery Exchange, LLC
1000 Brown Street, Suite #206
Wauconda, IL 60084
PMA NumberP190013
Date Received04/29/2019
Decision Date02/02/2021
Product Code MKJ 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE). The AED battery supplies power to an AED as required during self maintenance, automated diagnoses, and defibrillation. The 9146-ABE is indicated for use with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E. The G5-ABE is indicated for use with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C. The 5070-ABE is indicated for use with the Philips HeartStart OnSite/Home, models M5066A, M5067A, M5068A, and the FRx, model 861304. The FR3-ABE is indicated for use with the Philips HeartStart FR3, models 861388 and 861389.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
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