Boston Scientific Corporationone Scimed Placemaple Grove Mn 55311 Pma Numberp150003 Supplement Numbers085 Date Received04 07 2022 Decision Date05 06 2022 Product Code Niq 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 Boston Scientific Corporationone Scimed Placemaple Grove Mn 55311 Pma Numberp150003 Supplement Numbers085 Date Received04 07 2022 Decision Date05 06 2022 Product Code Niq 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 P150003S085 BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311 PMA NumberP150003 Supplement NumberS085 Date Received04/07/2022 Decision Date05/06/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	SYNERGY Drug Eluting Coronary Stent System	2022-05-06