Philips Medical Systems22100 Bothell Everett Hwybothell Wa 98021 Pma Numberp180028 Supplement Numbers012 Date Received02 22 2022 Decision Date03 20 2022 Product Code Mkj Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Philips Medical Systems22100 Bothell Everett Hwybothell Wa 98021 Pma Numberp180028 Supplement Numbers012 Date Received02 22 2022 Decision Date03 20 2022 Product Code Mkj Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P180028S012 Philips Medical Systems22100 Bothell Everett Hwybothell, WA 98021 PMA NumberP180028 Supplement NumberS012 Date Received02/22/2022 Decision Date03/20/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	HeartStart FRx Defibrillator	2022-03-20