Boston Scientific4100 Hamline Avenue Northst Paul Mn 55112 Pma Numberp960040 Supplement Numbers481 Date Received09 20 2022 Decision Date09 27 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 Numbers481 Date Received09 20 2022 Decision Date09 27 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 P960040S481 BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960040 Supplement NumberS481 Date Received09/20/2022 Decision Date09/27/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ORIGEN™ MINI ICD VR, ORIGEN MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN MINI ICD	2022-09-27