Medtronic Sofamor Danek Usa Inc 1800 Pyramid Placememphis Tn 38132 Pma Numberp000028 Supplement Numbers008 Date Received04 20 2006 Decision Date07 25 2006 Reclassified Date 07 12 2007 Product Code Max Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Medtronic Sofamor Danek Usa Inc 1800 Pyramid Placememphis Tn 38132 Pma Numberp000028 Supplement Numbers008 Date Received04 20 2006 Decision Date07 25 2006 Reclassified Date 07 12 2007 Product Code Max Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee 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 P000028S008 Medtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000028 Supplement NumberS008 Date Received04/20/2006 Decision Date07/25/2006 Reclassified Date 07/12/2007 Product Code MAX  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	AFFINITY ANTERIOR CERVICAL CAGE SYSTEM	2006-07-25