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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.
 
DeviceM5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge
Generic NameOver-the-counter automated external defibrillator
ApplicantPhilips Medical Systems, Inc.
22100 Bothell-Everett Hwy.
Bothell, WA 98021
PMA NumberP160029
Supplement NumberS018
Date Received11/18/2022
Decision Date02/16/2023
Product Codes MKJ NSA 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to implement a strip of double sided tape to the leading edge of the hydrogel layer of the HS1 SMART pads.
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