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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.
 
DeviceHeartStart FRx Defibrillator (861304)
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhilips Medical Systems
22100 Bothell Everett Hwy.
Bothell, WA 98021
PMA NumberP180028
Supplement NumberS011
Date Received10/18/2021
Decision Date11/15/2021
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  
Updates to the test limits of the Final Acceptance Test.
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