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Device | HeartStart OnSite Defibrillator and HeartStart Home Defibrillator |
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 | S012 |
Date Received | 05/21/2021 |
Decision Date | 06/15/2021 |
Product Codes |
MKJ NSA |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement New battery end of line test equipment for the HS1 and FRx Primary Battery, and the FRx Aviation Battery at the contract manufacturer. |