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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 15 monitor/defibrillator
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control, Inc.
11811 Willows Rd. NE
Redmond, WA 98052
PMA NumberP160026
Supplement NumberS003
Date Received11/09/2018
Decision Date12/06/2018
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  
Change in the manufacturing site location of the supplier of a critical grounding component.
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