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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.
 
DeviceLIFEPAK Automated External Defibrillators
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control, Inc.
11811 Willows Rd. NE
Redmond, WA 98052
PMA NumberP160026
Supplement NumberS020
Date Received06/17/2020
Decision Date09/16/2020
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 of the removal of a redundant capacitor C181 that causes physical interference between the C181 capacitor and front case assembly.
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