AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

FDA Premarket Approval P000028 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
• Generic Name: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Medtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000028 Supplement NumberS003 Date Received11/08/2002 Decision Date07/02/2003 Reclassified Date 07/12/2007 Product Code MAX Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Express Gmp Supplement Expedited Review Granted? No
• Date Received: 2002-11-08
• Decision Date: 2003-07-02
• PMA: P000028
• Supplement: S003
• Product Code: MAX
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Express Gmp Supplement
• Expedited Review: No
• Combination Product: No
• Applicant Address: Medtronic Sofamor Danek USA, Inc.; 1800 Pyramid Place; memphis, TN 38132 PMA NumberP000028 Supplement NumberS003 Date Received11/08/2002 Decision Date07/02/2003 Reclassified Date 07/12/2007 Product Code MAX Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Express Gmp Supplement Expedited Review Granted? No Combination ProductNo Approval Order Statement ; APPROVAL FOR ADDITIONAL MANUFACTURING FACILITY TO PERFORM PACKAGING FOR TERMINAL STERILIZATION. THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK, WARSAW, INDIANA. ALSO, APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA STERIGENICS, WESTERVILLE, OHIO AND AN ADDITIONAL TESTING FACILITY LOCATED AD NAMSA, NORTHWOOD, OHIO.

Supplemental Filings

Supplement Number	Date	Supplement Type
P000028		Original Filing
S008	2006-04-20	Normal 180 Day Track No User Fee
S007
S006	2004-07-30	30-day Notice
S005	2004-05-19	Special (immediate Track)
S004	2003-08-27	Normal 180 Day Track No User Fee
S003	2002-11-08	Normal 180 Day Track
S002	2002-07-15	Normal 180 Day Track
S001	2002-07-09	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
00721902307867	P000028	000
00721902307676	P000028	000
00721902307690	P000028	000
00721902307706	P000028	000
00721902307713	P000028	000
00721902307737	P000028	000
00721902307775	P000028	000
00721902307782	P000028	000
00721902307805	P000028	000
00721902307829	P000028	000
00721902307836	P000028	000
00721902307843	P000028	000
00721902307850	P000028	000
00721902307652	P000028	000