Boston Scientific Corporationone Scimed Placemaple Grove Mn 55311 1566 Pma Numberp980033 Supplement Numbers061 Date Received11 14 2022 Decision Date11 28 2022 Product Code Qkj 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 1566 Pma Numberp980033 Supplement Numbers061 Date Received11 14 2022 Decision Date11 28 2022 Product Code Qkj 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 P980033S061 BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311-1566 PMA NumberP980033 Supplement NumberS061 Date Received11/14/2022 Decision Date11/28/2022 Product Code QKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	WALLSTENT™ Venous Endoprosthesis with Unistep Plus™ Delivery System	2022-11-28