This page includes the latest FDA filings for Boston Scientific Corporationone Scimed Placemaple Grove Mn 55311 Pma Numberp150003 Supplement Numbers089 Date Received11 14 2022 Decision Date11 28 2022 Product Code Niq 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.
Device Company | Device | Date |
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BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311 PMA NumberP150003 Supplement NumberS089 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent Systems | 2022-11-28 |