Boston Scientific Corp One Scimed Placemaple Grove Mn 55311 Pma Numberp180011 Supplement Numbers051 Date Received10 18 2022 Decision Date11 07 2022 Product Code Niu 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 Corp One Scimed Placemaple Grove Mn 55311 Pma Numberp180011 Supplement Numbers051 Date Received10 18 2022 Decision Date11 07 2022 Product Code Niu 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 P180011S051 Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311 PMA NumberP180011 Supplement NumberS051 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ELUVIA Drug-Eluting Vascular Stent System	2022-11-07