The following data is part of a premarket notification filed by Advanced Neuromodulation Systems, Inc. (ans Inc.) with the FDA for Rapid Programmer, Version 3.3.0.
| Device ID | K091993 |
| 510k Number | K091993 |
| Device Name: | RAPID PROGRAMMER, VERSION 3.3.0 |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.) 6901 PRESTON ROAD Plano, TX 75024 |
| Contact | Mia M Ware |
| Correspondent | Mia M Ware ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.) 6901 PRESTON ROAD 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 | 2009-07-02 |
| Decision Date | 2009-07-31 |