FDA applicant
Boston Scientific Neuromodulation
FDA records 11 decisions for Boston Scientific Neuromodulation (Valencia, CA) from 2015 to 2025: 10 510(k) clearances and 1 original PMA approval. Most are in product codes GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)) and GZF (Stimulator, Peripheral Nerve, Implanted (Pain…). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 7 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Boston Scientific Neuromodulation Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Boston Scientific Neuromodulation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Boston Scientific 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) ReportOther applicant names beginning “Boston”
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