Apollo Endosurgery Inc1120 S Capital Of Tx Hwybldg 1 Ste 300austin Tx 78746 0000 Pma Numberp140008 Supplement Numbers024 Date Received07 11 2022 Decision Date10 05 2022 Product Code Lti Advisory Committee Gastroenterology Urology Supplement Typereal Time Process Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Apollo Endosurgery Inc1120 S Capital Of Tx Hwybldg 1 Ste 300austin Tx 78746 0000 Pma Numberp140008 Supplement Numbers024 Date Received07 11 2022 Decision Date10 05 2022 Product Code Lti Advisory Committee Gastroenterology Urology Supplement Typereal Time Process 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 Registration(s)

FDA Filings

Device
Company
DeviceDate
APOLLO ENDOSURGERY INC1120 S Capital Of Tx Hwybldg 1, Ste 300austin, TX 78746-0000 PMA NumberP140008 Supplement NumberS024 Date Received07/11/2022 Decision Date10/05/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
ORBERA ® Intragastric Balloon (IGB) System2022-10-05

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