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Device | M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge |
Generic Name | Over-the-counter automated external defibrillator |
Applicant | PHILIPS MEDICAL SYSTEMS, INC. 22100 BOTHELL -EVERETT HWY BOTHELL, WA 98021 |
PMA Number | P160029 |
Supplement Number | S018 |
Date Received | 11/18/2022 |
Decision Date | 02/16/2023 |
Product Codes |
MKJ NSA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |