Ebi Llc1 Gatehall Drivesuite 303parsippany Nj 07054 Pma Numberp850035 Supplement Numbers057 Date Received05 27 2022 Decision Date08 25 2022 Product Code Loe Advisory Committee Orthopedic Supplement Typereal Time Process Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Ebi Llc1 Gatehall Drivesuite 303parsippany Nj 07054 Pma Numberp850035 Supplement Numbers057 Date Received05 27 2022 Decision Date08 25 2022 Product Code Loe Advisory Committee Orthopedic Supplement Typereal Time Process 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 P850035S057 EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP850035 Supplement NumberS057 Date Received05/27/2022 Decision Date08/25/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	SpF Implantable Spinal Fusion Stimulators	2022-08-25