Boston Scientific Corp 100 Boston Scientific Waymarlborough Ma 01752 Pma Numbern970012 Supplement Numbers191 Date Received03 22 2022 Decision Date04 20 2022 Product Code Jcw 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 Numbern970012 Supplement Numbers191 Date Received03 22 2022 Decision Date04 20 2022 Product Code Jcw 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 N970012S191 Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberN970012 Supplement NumberS191 Date Received03/22/2022 Decision Date04/20/2022 Product Code JCW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™	2022-04-20