The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Renew Receiver.
| Device ID | K992946 |
| 510k Number | K992946 |
| Device Name: | RENEW RECEIVER |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
| Contact | Katryna Warren |
| Correspondent | Katryna Warren 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 | 1999-09-01 |
| Decision Date | 1999-09-24 |
| Summary: | summary |