The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Renew Neurostimulation System.
| Device ID | K000852 |
| 510k Number | K000852 |
| Device Name: | RENEW NEUROSTIMULATION SYSTEM |
| Classification | Stimulator, Peripheral Nerve, 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 | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-15 |
| Decision Date | 2001-01-19 |