Boston Scientific Corp 4100 Hamline Ave Northst Paul Mn 55112 Pma Numberp010012 Supplement Numbers553 Date Received04 04 2022 Decision Date04 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 Numbers553 Date Received04 04 2022 Decision Date04 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 P010012S553 Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS553 Date Received04/04/2022 Decision Date04/13/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Tachy DF4 header core	2022-04-13