The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Modification To Axxess Spinal Cord Stimulation Lead.
| Device ID | K030674 |
| 510k Number | K030674 |
| Device Name: | MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
| Contact | Drew Johnson |
| Correspondent | Drew Johnson ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-04 |
| Decision Date | 2003-03-28 |