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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.
 
DevicePowerheart® G3, G3 Plus and G5 AEDs
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 mill road
chelmsford, MA 01824
PMA NumberP160033
Supplement NumberS004
Date Received08/01/2019
Decision Date08/20/2019
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update to the Smart Packing Software to automate a verification step.
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