Abbott Vascular Cardiac Therapies3200 Lakeside Dr Santa Clara Ca 95054 2807 Pma Numberp110043 Supplement Numbers013 Date Received08 09 2022 Decision Date09 07 2022 Product Code Nio 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 Abbott Vascular Cardiac Therapies3200 Lakeside Dr Santa Clara Ca 95054 2807 Pma Numberp110043 Supplement Numbers013 Date Received08 09 2022 Decision Date09 07 2022 Product Code Nio 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 P110043S013 ABBOTT VASCULAR-CARDIAC THERAPIES3200 Lakeside Dr.santa Clara, CA 95054-2807 PMA NumberP110043 Supplement NumberS013 Date Received08/09/2022 Decision Date09/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Omnilink Elite™ Vascular Balloon-Exoandable Stent System	2022-09-07