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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 NumberS005
Date Received07/06/2020
Decision Date08/03/2020
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the inspection procedure for components and sub-assemblies used to build the HeartStart family of defibrillators.
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