Biosense Webster Inc 31 Technology Drivesuite 200irvine Ca 92618 Pma Numberp030031 Supplement Numbers128 Date Received09 02 2022 Decision Date09 30 2022 Product Code Oad 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 Numberp030031 Supplement Numbers128 Date Received09 02 2022 Decision Date09 30 2022 Product Code Oad 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 P030031S128 BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS128 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter	2022-09-30