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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.
 
DeviceAvive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantAvive Solutions, Inc.
185 Valley Dr.
Brisbane, CA 94005
PMA NumberP210015
Supplement NumberS002
Date Received02/16/2024
Decision Date08/15/2024
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 an alternate contract manufacturing facility for final assembly and packaging
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