Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Boston Scientific Neuromodulation

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories3
Latest Approval2024-08-23
TypeNumberDevice NameCodeDate
510(k) K233801 Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation GZB 2024-08-23 View
510(k) K232415 Nalu Neurostimulation System for Peripheral Nerve Stimulation GZF 2024-08-21 View
510(k) K221376 Nalu Neurostimulation System GZB 2022-06-10 View
510(k) K203547 Nalu Neurostimulation System GZB 2021-03-25 View
510(k) K202274 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 GZB 2020-11-09 View
510(k) K201618 Nalu Neurostimulation SCS system GZB 2020-07-15 View
510(k) K190960 Nalu Lead Blank (50cm) GZB 2019-07-11 View
510(k) K183579 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 GZF 2019-03-29 View
510(k) K183047 Nalu Neurostimulation System GZB 2019-03-22 View
PMA P140004 Prosthesis, spinous process spacer/plate NQO 2016-10-11 View