Biosense Webster Inc 31 Technology Drivesuite 200irvine Ca 92618 Pma Numberp990071 Supplement Numbers054 Date Received05 18 2022 Decision Date06 08 2022 Product Code Lpb 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 Numberp990071 Supplement Numbers054 Date Received05 18 2022 Decision Date06 08 2022 Product Code Lpb 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 P990071S054 BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	SmartAblate Irrigation Tubing Set and nGEN Pump	2022-06-08