Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits

About This 510(k) Submission

K202274 is an FDA 510(k) clearance for the Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits, a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II — Special Controls, product code GZB), submitted by Boston Scientific Neuromodulation (Carlsbad, US). The FDA issued a Cleared decision on November 9, 2020, 90 days after receiving the submission on August 11, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5880.