Philips Medical Systems Inc 22100 Bothell Everett Hwybothell Wa 98021 Pma Numberp160029 Supplement Numbers017 Date Received07 05 2022 Decision Date07 27 2022 Product Codes Nsa 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 Systems Inc 22100 Bothell Everett Hwybothell Wa 98021 Pma Numberp160029 Supplement Numbers017 Date Received07 05 2022 Decision Date07 27 2022 Product Codes Nsa 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 P160029S017 PHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS017 Date Received07/05/2022 Decision Date07/27/2022 Product Codes NSA MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507	2022-07-27