Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

About This 510(k) Submission

K183579 is an FDA 510(k) clearance for the Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits, a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II — Special Controls, product code GZF), submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on March 29, 2019, 98 days after receiving the submission on December 21, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5870.