The following data is part of a premarket notification filed by Advanced Neuromodulation System,inc with the FDA for Lamitrode S-series (s4 And S8) Leads.
| Device ID | K022222 |
| 510k Number | K022222 |
| Device Name: | LAMITRODE S-SERIES (S4 AND S8) LEADS |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEM,INC 6501 WINDCREST DRIVE,SUTE 100 Plano, TX 75024 |
| Contact | Katryna Warren |
| Correspondent | Katryna Warren ADVANCED NEUROMODULATION SYSTEM,INC 6501 WINDCREST DRIVE,SUTE 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 | 2002-07-09 |
| Decision Date | 2002-08-08 |