This page includes the latest FDA filings for Biosense Webster Inc 31 Technology Drivesuite 200irvine Ca 92618 Pma Numberp040036 Supplement Numbers089 Date Received06 10 2022 Decision Date09 09 2022 Product Code Lpb Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material 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 |
|---|---|---|
| BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No | NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) | 2022-09-09 |