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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.
 
DeviceInfant/Child Reduced Energy Defibrillation Electrodes
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control. Inc.
11811 Willows Rd. NE
Redmond, WA 98052
PMA NumberP160012
Supplement NumberS003
Date Received01/30/2020
Decision Date07/08/2021
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Infant/Child Reduced Energy Defibrillation electrode for use with the LIFEPAK 1000, LIFEPAK CRO Plus, and LIFEPAK EXPRESS defibrillators.
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