Spatz Fgia Inc 1801 S Perimeter Rdsuite 130ft Lauderdale Fl 33309 Pma Numberp190012 Supplement Numbers003 Date Received01 05 2023 Decision Date01 23 2023 Product Code Lti Advisory Committee Gastroenterology Urology 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 Spatz Fgia Inc 1801 S Perimeter Rdsuite 130ft Lauderdale Fl 33309 Pma Numberp190012 Supplement Numbers003 Date Received01 05 2023 Decision Date01 23 2023 Product Code Lti Advisory Committee Gastroenterology Urology 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 P190012S003 Spatz FGIA Inc.1801 S Perimeter Rdsuite 130ft. Lauderdale, FL 33309 PMA NumberP190012 Supplement NumberS003 Date Received01/05/2023 Decision Date01/23/2023 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	Spatz3 Adjustable Balloon System	2023-01-23