Boston Scientific Corporation4100 Hamline Avenue Northst Paul Mn 55112 5798 Pma Numberp110042 Supplement Numbers176 Date Received11 10 2022 Decision Date12 07 2022 Product Codes Lws Nvy 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 Corporation4100 Hamline Avenue Northst Paul Mn 55112 5798 Pma Numberp110042 Supplement Numbers176 Date Received11 10 2022 Decision Date12 07 2022 Product Codes Lws Nvy 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 P110042S176 BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS176 Date Received11/10/2022 Decision Date12/07/2022 Product Codes LWS NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)	2022-12-07