The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Tripole 8c And 16c And Exclaim 8 Lamitrode Series Leads.
| Device ID | K063080 |
| 510k Number | K063080 |
| Device Name: | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Amy Clendening |
| Correspondent | Amy Clendening ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. 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 | 2006-10-10 |
| Decision Date | 2006-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067017758 | K063080 | 000 |
| 05414734401883 | K063080 | 000 |