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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 G5 Pediatric Electrodes
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160033
Supplement NumberS006
Date Received04/22/2021
Decision Date10/07/2021
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new supplier for the pediatric electrode for the Powerheart G5 Automated External Defibrillator.
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