The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Penta Lead Kits, Models: 3227-3234.
| Device ID | K090907 |
| 510k Number | K090907 |
| Device Name: | PENTA LEAD KITS, MODELS: 3227-3234 |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Amy Clendening |
| Correspondent | Amy Clendening ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-06-02 |