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 NumberS004 Date Received08/27/2003 Decision Date11/13/2003 Reclassified Date 07/12/2007 Product Code MAX Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2003-08-27 |
| Decision Date | 2003-11-13 |
| PMA | P000028 |
| Supplement | S004 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132 PMA NumberP000028 Supplement NumberS004 Date Received08/27/2003 Decision Date11/13/2003 Reclassified Date 07/12/2007 Product Code MAX Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement APPROVAL FOR A REVISED EXPLANT PROTOCOL. |
| 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 |