FDA applicant
St. Jude Medical Neuromodulation
FDA records 2 decisions for St. Jude Medical Neuromodulation (Plano, TX) from 2011 to 2013: 2 510(k) clearances. All are in product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided St. Jude Medical Neuromodulation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
2in 2014
Class I Class II/III not classified
Planning a device like St. Jude Medical Neuromodulation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report