Boston Scientific Corp Ballybrit Industrial Estate Ballybritgalway H91 Y Pma Numberp110035 Supplement Numbers068 Date Received10 18 2022 Decision Date11 07 2022 Product Code Nio 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 Ballybrit Industrial Estate Ballybritgalway H91 Y Pma Numberp110035 Supplement Numbers068 Date Received10 18 2022 Decision Date11 07 2022 Product Code Nio 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 P110035S068 Boston Scientific Corp.ballybrit Industrial Estate, Ballybritgalway H91 Y PMA NumberP110035 Supplement NumberS068 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	EPIC Vascular Self-Expanding Stent System	2022-11-07