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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 (AED)
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
Physio-Control, Inc
11811 willows road ne
redmond, WA 98052
PMA NumberP170018
Supplement NumberS006
Date Received04/23/2020
Decision Date05/20/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to create a duplicate manufacturing line for the LIFEPAK CR2 defibrillator.
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