Irvine Biomedical Inc Ibi 2375 Morse Ave Irvine Ca 92614 Pma Numberp040042 Supplement Numbers052 Date Received10 19 2022 Decision Date11 15 2022 Product Code Oad Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Irvine Biomedical Inc Ibi 2375 Morse Ave Irvine Ca 92614 Pma Numberp040042 Supplement Numbers052 Date Received10 19 2022 Decision Date11 15 2022 Product Code Oad 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.

FDA Filings

Device Company	Device	Date
PMA P040042S052 IRVINE BIOMEDICAL,INC.(IBI)2375 Morse Ave.irvine, CA 92614 PMA NumberP040042 Supplement NumberS052 Date Received10/19/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable	2022-11-15