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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 Defibrillator
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhilips Medical Systems, Inc.
22100 Bothell-Everett Hwy.
Bothell, WA 98021
PMA NumberP160028
Supplement NumberS001
Date Received07/06/2020
Decision Date08/03/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the inspection procedure for components and sub-assemblies used to build the HeartStart family of defibrillators.
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