510(k) K123299 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
| Applicant | St. Jude Medical Neuromodulation, Plano TX, US |
| Decision | Substantially Equivalent, Jan 18, 2013 |
| Received | Oct 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2014 | St. Jude Medical, Inc. Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead).
Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. Terminated |
GZB | None listed |
| Sep 29, 2014 | St. Jude Medical, Inc. Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead).
Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. Terminated |
GZB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.