The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Lamitrode Spinal Cord Stimulation Leads.
| Device ID | K033429 |
| 510k Number | K033429 |
| Device Name: | LAMITRODE SPINAL CORD STIMULATION LEADS |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
| Contact | Danielle Alarcon |
| Correspondent | Danielle Alarcon 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 | 2003-10-28 |
| Decision Date | 2003-12-04 |