St Jude Medical Inc Irvine Biomedical 2375 Morse Avenueirvine Ca 92614 6233 Pma Numberp110016 Supplement Numbers081 Date Received11 14 2022 Decision Date12 08 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 St Jude Medical Inc Irvine Biomedical 2375 Morse Avenueirvine Ca 92614 6233 Pma Numberp110016 Supplement Numbers081 Date Received11 14 2022 Decision Date12 08 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 P110016S081 St. Jude Medical, Inc. (Irvine Biomedical)2375 Morse Avenueirvine, CA 92614-6233 PMA NumberP110016 Supplement NumberS081 Date Received11/14/2022 Decision Date12/08/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	FlexAbility Ablation Catheter / FlexAbility Ablation Catheter, Sensor Enabled (SE)	2022-12-08