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 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 |
| Date Received | 2006-04-20 |
| Decision Date | 2006-07-25 |
| PMA | P000028 |
| Supplement | S008 |
| Product Code | MAX |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, 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 Combination ProductNo Approval Order Statement APPROVAL FOR CHANGES TO THE DEVICE LABELING TO INCORPORATE DATA COLLECTED FROM THE POST MARKET STUDY OF THE DEVICE. |
| 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 |