Boston Scientific Corp 4100 Hamline Ave Northst Paul Mn 55112 Pma Numberp010012 Supplement Numbers555 Date Received06 29 2022 Decision Date07 13 2022 Product Code Nik 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 4100 Hamline Ave Northst Paul Mn 55112 Pma Numberp010012 Supplement Numbers555 Date Received06 29 2022 Decision Date07 13 2022 Product Code Nik 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 P010012S555 Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS555 Date Received06/29/2022 Decision Date07/13/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR	2022-07-13