Boston Scientific Neuromodulation Corporation

FDA Device Registration & Listing · Valencia, CA, US · Registration 3006630150

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006630150
FEI Number
3006630150
Entity Name
Boston Scientific Neuromodulation Corporation
City/State/Country
Valencia, CA, US
Establishment Address
25155 Rye Canyon Loop, Valencia, CA 91355, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Boston Scientific Corporation (Owner Number: 9912058)
Owner / Operator Contact Address
300 Boston Scientific Way, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K113805
PMA Number
N/A

All Registered Proprietary Names

Precision Battery AAA 1.5 Alkaline Precision Charger Artisan Surgical Lead Kit Cable, USB Serial Precision Spectra Patient Trial Belt Precision Lead Blank O.R. Cable and Extension Precision Spectra External Trial Stimulator Precision AC/DC Power Supply Charger Belt Extension Precision Precision Spectra Remote Control Enhanced Steering Kit with Stylet Cap Introducer Remote Control Silicone Case Clik X MRI Anchor D4 Splitter Kit Spectra WaveWriter Implantable Pulse Generator and Charging Kit Precision Patient Trial Belt Linear 3-6 Lead Kit USB Splitter Power Unlimited, Power Adapter Precision Implantable Pulse Generator and Charging Kit Precision Adhesive Kit Clik X Anchor Precision Novi Implantable Pulse Generator Kit Precision IPG Port Plug Precision Lithium Manganese Dioxide Battery 6 Volts Precision Cable, USB-Serial Patient Trial Kit Linear 3-4 Lead Kit Spectra WaveWriter External Trial Stimulator Precision IRDA Dongle Holder Charger Spacer Precision Spectra IPG Port Plug Precision Patient Trial Kit Tablet Pen Charger Belt Loops Replacement Paddle Blank for CoverEdge 32 Surgical Lead Precision Connector Clinician Programmer Insertion Needle Precision OMG Connector-A Precision Primary Lithium Battery AA Type STD Precision Charging System Kit Precision Base Station Precision External Trial Stimulator Linear Precision Tablet PC Pen Spectra Implantable Pulse Generator and Charging Kit CoverEdge X 32 Surgical Lead Kit Splitter Kit Precision Passing Elevator Programming Wand Spectra Implantable Pulse Generator Kit Charger Belt Precision Epimed Needle Clik Anchor Hex Wrench Medical Adhesive Precision PC SC-7150 CoverEdge 32 Surgical Lead Kit Installer for BN3.1 Entrada Needle Precision Suture Sleeve Precision Remote Control Case Precision Charging Belt Precision Patient Controller Entrada Spare Sheath Precision Hex Wrench Precision S8 Adapter Precision OMG Connector-M Power Supply for Tablet Computer USB Power Supply Remote Control (U.S.) Precision Power Supply & Adapter For Charger Precision Clinician Programmer Stylet Kit with Stylet Cap Precision Spectra OMG Adapter Extension Kit Precision Montage MRI Implantable Pulse Generator Kit Precision Patient Programmer Kit Infinion Lead Kit W4 Splitter Kit Precision Holster Click Anchor Spectra External Trial Stimulator Linear ST Lead Kit Avista MRI Lead Kit Infinion CX Lead Kit Tunneling Tool SCS Implantable Materials Kit Linear Lead Kit Precision Spectra Remote Control Kit Spectra WaveWriter Implantable Pulse Generator Precision Spectra Implantable Pulse Generator Kit Paddle Blank for CoverEdge X 32 Surgical Lead Remote Control Holster Precision Implantable Pulse Generator Kit Precision Remote Control Artisan MRI Surgical Lead Kit Bionic Navigator 3D Installer Keyboard Precision Spectra Implantable Pulse Generator and Charging Kit Precision Spectra Patient Trial Kit Precision IR Interface Precision Montage MRI Implantable Pulse Generator and Charging Kit Precision Montage Implantable Pulse Generator Kit Precision M8 Adapter WaveWriter Alpha 16 IPG and Charging Kit CoverEdge X MRI 4x8 Surgical Lead Kit WaveWriter Alpha IPG and Charging Kit Pairing Magnet WaveWriter Alpha ETS Bionic Navigator 3D 4 Installer Freelink Remote Control WaveWriter Alpha IPG Kit CoverEdge MRI 4x8 Surgical Lead Kit WaveWriter Alpha ETS Trial Belt Freelink Remote Control Kit WaveWriter Alpha Prime IPG Kit WaveWriter Alpha 16 IPG Kit WaveWriter Alpha Patient Trial Kit Bionic Navigator Installer WaveWriter Alpha Prime 16 IPG Kit Bionic Navigator 3D 4.1 Installer mySCS GO Therapy Controller Clinician Kit mySCS GO Therapy Controller App Infinion Pro Lead Kit mySCS GO Therapy Controller Patient Kit mySCS GO Therapy Controller App Patient Literature Kit Single Use Instrument (SUI) Kit Superion IDS, 10 mm Superion IDS, 14 mm Superion IDS, 16 mm Superion IDS, 8 mm Superion IDS, 12 mm Vertiflex Instrument Platform (VIP) Kit Vercise DBS Controller Clinician Kit Vercise Physician's Spare Kit 8 Contact Extension Kit Vercise M8 Adapter Vercise Remote Control Vercise External Trial Stimulator Base Station Charger Clinician Programmer Power Supply for Tablet Computer Vercise Implantable Pulse Generator Kit Vercise Remote Control Kit Precision AC/DC Power Supply Bionic Navigator 24 Installer Tunneling Tool Cable, USB Serial Keyboard Patient Travel Case Remote Control Case Medical Adhesive Adhesive Kit Tablet Pen IR Interface ETS battery Vercise Charger Collar Charger Spacer SureTek Burr Hole Cover Kit Lead Kit Vercise Charging System Vercise DBS External Trial Stimulator 2 IR Interface Holder USB Splitter O.R. Cable and Extension Vercise Charger Collar Accessories Vercise PC Implantable Pulse Generator Kit AC/DC Power Supply Vercise Neural Navigator 2.1 Installer OR Cable 2x8, 61cm and Extension Precision Spectra IPG Port Plug Programming Wand SP3 Platform Update Installer Vercise DBS Remote Control 3 Vercise Gevia Implantable Pulse Generator Kit Vercise ETS Vercise DBS Remote Control 3 Kit Vercise DBS Directional Lead Kit Vercise Genus Implantable Pulse Generator Kits Pairing Magnet Vercise Neural Navigator 4 Installer Vercise DBS Remote Control 4 and Kit Vercise Neural Navigator 3.1 Installer Vercise ETS 3 Charger Belt and accessories Vercise Charging System with Belt Push Button OR Cable 2x8 Contact Lead Extension Kit Vercise Charger Vercise Neural Navigator 5 Vercise S8 Adapter Vercise ETS Adapter Vercise Physician's Spare Kit, 16 Contact Lead Vercise DBS Controller Vercise Cartesia HX Directional Lead Kit Lead Extension Kit, 16 Contact Vercise Cartesia X Directional Lead Kit Vercise DBS Controller Patient Kit Vercise Cartesia Directional Lead Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2016-08-25
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2016-08-25
QRB Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy Unknown Class 3 N/A 2007-11-19
LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown Class 3 N/A 2007-11-19
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2023-12-15
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2023-12-15
NQO Prosthesis, Spinous Process Spacer/Plate Unknown Class 3 N/A 2019-11-14
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2023-12-15
PJS Stimulator, Electrical, Implanted, For Essential Tremor Unknown Class 3 N/A 2017-12-10
MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor Unknown Class 3 N/A 2017-12-10
NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Unknown Class 3 N/A 2017-12-10
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2025-09-05
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2019-03-13
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2016-08-25
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2016-08-25
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2016-08-25
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2013-03-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-03-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boston Scientific Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3025434462 Obsidio Inc Maple Grove, MN, US
3005619880 Boston Scientific Corporation Roswell, GA, US
3015425075 NALU MEDICAL Carlsbad, CA, US
3015289131 FARAPULSE, INC. Menlo Park, CA, US
3022298579 Boston Scientific Cardiac Diagnostic Technologies, Inc. Arden Hills, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K020354 Baylis Medical Co., Inc. BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) 2002-05-03
K201610 ABBOTT MEDICAL IonicRF Generator 2020-10-21
K253907 ABBOTT MEDICAL Disposable Radiofrequency Cannula 2026-04-16
K242841 ABBOTT MEDICAL Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) 2025-05-27
K190960 Boston Scientific Neuromodulation Nalu Lead Blank (50cm) 2019-07-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006630150. Last updated year: 2026. Please use registration number 3006630150 when referencing this establishment in official correspondence.
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