The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Modification To Renew Lead Extension.
| Device ID | K032751 |
| 510k Number | K032751 |
| Device Name: | MODIFICATION TO RENEW LEAD EXTENSION |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
| Contact | Danielle Alarcon |
| Correspondent | Danielle Alarcon 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 | 2003-09-05 |
| Decision Date | 2003-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734402330 | K032751 | 000 |
| 05414734402309 | K032751 | 000 |