The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Multi Lead Trial Cable.
| Device ID | K130545 |
| 510k Number | K130545 |
| Device Name: | MULTI LEAD TRIAL CABLE |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
| Contact | Lakshmi Padmanabhan |
| Correspondent | Lakshmi Padmanabhan ST. JUDE MEDICAL 6901 PRESTON ROAD 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 | 2013-03-01 |
| Decision Date | 2013-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734405362 | K130545 | 000 |
| 05414734405355 | K130545 | 000 |
| 05414734405348 | K130545 | 000 |
| 05414734405331 | K130545 | 000 |