The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for A127 Lead Extension.
| Device ID | K030461 |
| 510k Number | K030461 |
| Device Name: | A127 LEAD EXTENSION |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
| Contact | Rashmi Moza |
| Correspondent | Rashmi Moza ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 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 | 2003-02-12 |
| Decision Date | 2003-04-24 |