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Boston Scientific Neuromodulation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for PeripheraAugust 23, 2024
K232415Nalu Neurostimulation System for Peripheral Nerve StimulationAugust 21, 2024
K221376Nalu Neurostimulation SystemJune 10, 2022
K203547Nalu Neurostimulation SystemMarch 25, 2021
K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 November 9, 2020
K201618Nalu Neurostimulation SCS systemJuly 15, 2020
K190960Nalu Lead Blank (50cm)July 11, 2019
K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2March 29, 2019
K183047Nalu Neurostimulation SystemMarch 22, 2019