Boston Scientific4100 Hamline Avenue Northst Paul Mn 55112 Pma Numberp960040 Supplement Numbers478 Date Received06 16 2022 Decision Date06 21 2022 Product Code Lws 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 Scientific4100 Hamline Avenue Northst Paul Mn 55112 Pma Numberp960040 Supplement Numbers478 Date Received06 16 2022 Decision Date06 21 2022 Product Code Lws 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 P960040S478 BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960040 Supplement NumberS478 Date Received06/16/2022 Decision Date06/21/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ICD INOGEN VR DF4, ICD INOGEN VR DF1/IS1, ICD INOGEN DR DF4/IS1, ICD INOGEN DR DF1/IS1, ICD DYNAGEN VR DF1/IS1, ICD DYNA	2022-06-21