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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 Home Defibrillator and HeartStart OnSite Defibrillator
Generic NameOver-the-counter automated external defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
22100 BOTHELL -EVERETT HWY
BOTHELL, WA 98021
PMA NumberP160029
Supplement NumberS009
Date Received01/21/2021
Decision Date02/12/2021
Product Codes MKJ NSA 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Inspection procedure changes for components and sub-assemblies used in the manufacture of the HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A) and HeartStart FRx Defibrillator (Model 861304).
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