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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceHeartStart FR3 Primary Battery (989803150161)
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhilips Medical Systems, Inc.
22100 Bothell-Everett Hwy.
Bothell, WA 98021
PMA NumberP160028
Supplement NumberS005
Date Received08/13/2024
Decision Date09/11/2024
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Panasonic Energy Mexico S.A. de C.V., Av. Santa Barbara 601, Col Ex-Ejido San Nicolas, Escobedo N.L. Mexico 66050.
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