Clearance Summary
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 received FDA 510(k) clearance under submission number K183579, sponsored by Boston Scientific Neuromodulation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-03-29.
- Submission: K183579
- Applicant / Sponsor: Boston Scientific Neuromodulation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5870
- Decision date: 2019-03-29
Classification & Regulation
This clearance is catalogued under FDA product code GZF and 21 CFR 882.5870, within the Neurology review panel as a Class II device.