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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® 20e defibrillator/monitor
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control. Inc.
11811 Willows Road NE
Redmond, WA 98052
PMA NumberP160026
Supplement NumberS006
Date Received04/11/2019
Decision Date05/09/2019
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Manufacturing process change that impacts the pulse oximetry (Sp02) module component of the LIFEPAK 20e defibrillator/monitor.
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