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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 AED
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160033
Supplement NumberS010
Date Received11/13/2023
Decision Date12/21/2023
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 two components on the printed circuit board assembly (PCBA) that are obsolete and six ancillary changes to the PCBA for ease of manufacturing.
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