Boston Scientific Corp 100 Boston Scientific Waymarlborough Ma 01752 Pma Numberp000053 Supplement Numbers127 Date Received08 19 2022 Decision Date09 01 2022 Product Code Ezy Advisory Committee Gastroenterology Urology 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 100 Boston Scientific Waymarlborough Ma 01752 Pma Numberp000053 Supplement Numbers127 Date Received08 19 2022 Decision Date09 01 2022 Product Code Ezy Advisory Committee Gastroenterology Urology 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 P000053S127 Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberP000053 Supplement NumberS127 Date Received08/19/2022 Decision Date09/01/2022 Product Code EZY  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	AMS 800™ Artificial Urinary Sphincter (AUS) with and without lnhibiZone™ Treatment	2022-09-01