The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Renew Lead Extension.
| Device ID | K991784 |
| 510k Number | K991784 |
| Device Name: | RENEW LEAD EXTENSION |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Katryna Warren |
| Correspondent | Katryna Warren ADVANCED NEUROMODULATION SYSTEMS ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 1999-06-24 |
| Summary: | summary |