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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 Defibrillator
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
Physio-Control, Inc
11811 willows road ne
redmond, WA 98052
PMA NumberP170018
Supplement NumberS004
Date Received09/11/2019
Decision Date10/23/2019
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to support a different configuration of the LIFEPAK CR2 defibrillator.
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