The following data is part of a premarket notification filed by St. Jude Medical Neuromodulation with the FDA for Mts System, Wide-space Quattrode Percutaneous Leads.
| Device ID | K123299 |
| 510k Number | K123299 |
| Device Name: | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ST. JUDE MEDICAL NEUROMODULATION 6901 PRESTON RD. Plano, TX 75024 |
| Contact | Terrina Wilder, Rac |
| Correspondent | Terrina Wilder, Rac ST. JUDE MEDICAL NEUROMODULATION 6901 PRESTON RD. Plano, TX 75024 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-23 |
| Decision Date | 2013-01-18 |
| Summary: | summary |