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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 HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A)
Generic NameOver-the-counter automated external defibrillator
ApplicantPhilips Medical Systems, Inc.
22100 Bothell-Everett Hwy.
Bothell, WA 98021
PMA NumberP160029
Supplement NumberS024
Date Received01/23/2024
Decision Date02/21/2024
Product Codes MKJ NSA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a battery manufacturing site located at Panasonic Energy Mexico, S.A. de C.V., Escobedo N.L., Mexico
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