Biosense Webster Inc 31 Technology Drivesuite 200irvine Ca 92618 Pma Numberp990025 Supplement Numbers070 Date Received09 02 2022 Decision Date09 30 2022 Product Code Drf 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 Biosense Webster Inc 31 Technology Drivesuite 200irvine Ca 92618 Pma Numberp990025 Supplement Numbers070 Date Received09 02 2022 Decision Date09 30 2022 Product Code Drf 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 P990025S070 BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,	2022-09-30