| |
| Trade Name | MEDTRONIC CAPSUREFIX NOVUS MODEL 4076 LEAD |
| Classification Name | permanent pacemaker electrode |
| Generic Name | pacing lead |
| Regulation Number | 870.3680 |
| Applicant | MEDTRONIC VASCULAR |
| PMA Number | P930039 |
| Supplement Number | S017 |
| Date Received | 11/13/2003 |
| Decision Date | 02/09/2004 |
| Product Code | |
| Advisory Committee |
Cardiovascular |
| Supplement Type | real-time process |
| Supplement Reason | change design/components/specifications - other |
| Expedited Review Granted? | No |
| Combination Product |
No
|
Approval Order Statement Approval for modifications to the model 4076 lead. |