510(k) K063080 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
| Applicant | Advanced Neuromodulation Systems, Plano TX, US |
| Decision | Substantially Equivalent, Dec 12, 2006 |
| Received | Oct 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063080
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.