This page includes the latest FDA filings for Irvine Biomedical Inc 2375 Morse Ave Irvine Ca 92614 Pma Numberp040014 Supplement Numbers047 Date Received10 28 2022 Decision Date12 16 2022 Product Code Lpb Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location 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.
Device Company | Device | Date |
|---|---|---|
| IRVINE BIOMEDICAL, INC.2375 Morse Ave.irvine, CA 92614 PMA NumberP040014 Supplement NumberS047 Date Received10/28/2022 Decision Date12/16/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) | 2022-12-16 |