Boston Scientific Corporation4100 Hamline Avenue Northst Paul Mn 55112 5798 Pma Numberp110042 Supplement Numbers169 Date Received04 25 2022 Decision Date05 18 2022 Product Codes Nvy Lws Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 Numbers169 Date Received04 25 2022 Decision Date05 18 2022 Product Codes Nvy Lws Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 P110042S169 BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS169 Date Received04/25/2022 Decision Date05/18/2022 Product Codes NVY LWS  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)	2022-05-18