Philips Medical Systems Inc 22100 Bothell Everett Hwybothell Wa 98021 Pma Numberp160029 Supplement Numbers016 Date Received05 11 2022 Decision Date06 08 2022 Product Codes Mkj Nsa 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 Systems Inc 22100 Bothell Everett Hwybothell Wa 98021 Pma Numberp160029 Supplement Numbers016 Date Received05 11 2022 Decision Date06 08 2022 Product Codes Mkj Nsa 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 P160029S016 PHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS016 Date Received05/11/2022 Decision Date06/08/2022 Product Codes MKJ NSA  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator	2022-06-08