The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Wide Spaced Quattrode Leads.
| Device ID | K072462 |
| 510k Number | K072462 |
| Device Name: | WIDE SPACED QUATTRODE LEADS |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ADVANCED NEUROMODULATION SYSTEMS 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Mia M Ware |
| Correspondent | Mia M Ware 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 | 2007-08-31 |
| Decision Date | 2007-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734406116 | K072462 | 000 |
| 05414734406109 | K072462 | 000 |
| 05414734406093 | K072462 | 000 |
| 05414734406017 | K072462 | 000 |
| 05414734401661 | K072462 | 000 |
| 05414734401647 | K072462 | 000 |
| 05414734401548 | K072462 | 000 |