Medical Device Manufacturer · US , Valencia , CA

Boston Scientific Neuromodulation

9 submissions · 9 cleared · Since 2019
9
Total
9
Cleared
0
Denied

Boston Scientific Neuromodulation — FDA 510(k) Submissions

Boston Scientific Neuromodulation has submitted 9 FDA 510(k) premarket notifications since 2019, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Spinal-cord, Implanted (pain Relief), Stimulator, Peripheral Nerve, Implanted (pain Relief) . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
K233801 · GZB Stimulator, Spinal-cord,... · Neurology
Aug 2024 268d
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · GZF Stimulator, Peripheral... · Neurology
Aug 2024 376d
Nalu Neurostimulation System
K221376 · GZB Stimulator, Spinal-cord,... · Neurology
Jun 2022 29d
Nalu Neurostimulation System
K203547 · GZB Stimulator, Spinal-cord,... · Neurology
Mar 2021 111d
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
K202274 · GZB Stimulator, Spinal-cord,... · Neurology
Nov 2020 90d
Nalu Neurostimulation SCS system
K201618 · GZB Stimulator, Spinal-cord,... · Neurology
Jul 2020 30d
Nalu Lead Blank (50cm)
K190960 · GZB Stimulator, Spinal-cord,... · Neurology
Jul 2019 90d
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
K183579 · GZF Stimulator, Peripheral... · Neurology
Mar 2019 98d
Nalu Neurostimulation System
K183047 · GZB Stimulator, Spinal-cord,... · Neurology
Mar 2019 140d
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