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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® 35 Monitor/Defibrillator
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control. Inc.
11811 Willows Road NE
Redmond, WA 98052
PMA NumberP160026
Supplement NumberS040
Date Received07/18/2023
Decision Date04/12/2024
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 AuthorizedYes
Approval Order Statement  
Approval for a new model of professional-use automated external defibrillator (AED), the LIFEPAK 35 Monitor/Defibrillator, the LIFEPAK Therapy Cable, LIFEPAK FLEX Lithium-Ion Battery and a Predetermined Change Control Plan (PCCP), dated April 10, 2024, for noninvasive blood pressure modules and cleaning modifications.
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