Bolton Medical Inc 799 I N T Pkwysunrise Fl 33325 Pma Numberp190015 Supplement Numbers010 Date Received12 23 2022 Decision Date01 20 2023 Product Code Mih Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Bolton Medical Inc 799 I N T Pkwysunrise Fl 33325 Pma Numberp190015 Supplement Numbers010 Date Received12 23 2022 Decision Date01 20 2023 Product Code Mih Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P190015S010 Bolton Medical Inc.799 International Pkwysunrise, FL 33325 PMA NumberP190015 Supplement NumberS010 Date Received12/23/2022 Decision Date01/20/2023 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	TREO® Abdominal Stent-Graft System	2023-01-20