Boston Scientific Corp 100 Boston Scientific Waymarlborough Ma 01752 Pma Numbern970012 Supplement Numbers194 Date Received11 01 2022 Decision Date11 14 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 Numbers194 Date Received11 01 2022 Decision Date11 14 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 N970012S194 Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberN970012 Supplement NumberS194 Date Received11/01/2022 Decision Date11/14/2022 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 (IPP) with and without InhibiZone™	2022-11-14