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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 CR2 Automated External Defibrillator
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control, Inc
11811 Willows Road NE
Redmond, WA 98052
PMA NumberP170018
Supplement NumberS012
Date Received01/25/2021
Decision Date02/16/2021
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new warning associated with premature battery depletion of the LIFEPAK CR2 lithium battery.
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