Bolton Medical Inc 799 I N T Parkwaysunrise Fl 33325 Pma Numberp110038 Supplement Numbers027 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 Parkwaysunrise Fl 33325 Pma Numberp110038 Supplement Numbers027 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 P110038S027 BOLTON MEDICAL, INC.799 International Parkwaysunrise, FL 33325 PMA NumberP110038 Supplement NumberS027 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	RelayPlus Thoracic Stent-Graft System	2023-01-20