Boston Scientific Corporationthree Scimed Placemaple Grove Mn 55311 1566 Pma Numberp190019 Supplement Numbers016 Date Received10 17 2022 Decision Date11 15 2022 Product Code Onu Advisory Committee Cardiovascular 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 Corporationthree Scimed Placemaple Grove Mn 55311 1566 Pma Numberp190019 Supplement Numbers016 Date Received10 17 2022 Decision Date11 15 2022 Product Code Onu 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.

FDA Filings

Device Company	Device	Date
PMA P190019S016 Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS016 Date Received10/17/2022 Decision Date11/15/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Ranger Paclitaxel-Coated PTA Balloon Catheter	2022-11-15