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.
| 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 NumberS001 Date Received07/09/2002 Decision Date08/13/2002 Reclassified Date 07/12/2007 Product Code MAX Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2002-07-09 |
| Decision Date | 2002-08-13 |
| PMA | P000028 |
| Supplement | S001 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 PMA NumberP000028 Supplement NumberS001 Date Received07/09/2002 Decision Date08/13/2002 Reclassified Date 07/12/2007 Product Code MAX Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES TO THE DEVICE: 1) MINOR DESIGN CHANGES TO THE CAGE, MAINLY CONSISTING OF MINOR CHANGES TO THE THREADS; 2) PROVIDE THE DEVICE STERILE; AND 3) CHANGE THE DEVICE NAME TO THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFFINITY ANTERIOR CERVICAL CAGE SYSTEM AND IS INDICATED FOR ANTERIOR CERVICAL INTERBODY FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH CERVICAL DISC DISEASE AT ONE LEVEL FROM THE C2-C3 DISC TO THE C7-T1 DISC. CERVICAL DISC DISEASE IS DEFINED AS INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY WITH HERNIATED DISC AND/OR OSTEOPHYTE FORMATION ON POSTERIOR VERTEBRAL ENDPLATES PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION CONFIRMED BY RADIOGRAPHIC STUDIES. AFFINITY IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH. |
| 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 |
| 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 |