Data / Medical devices / United States / Boston Scientific Neuromodulation Corporation
Boston Scientific Neuromodulation Corporation: FDA-registered device maker in Valencia, CA, United States, 13 510(k) clearances and 3 PMA approvals
Boston Scientific Neuromodulation Corporation is registered with the FDA (registration 3006630150) in Valencia, CA, United States. It lists 11 device types. The FDA files 13 510(k) clearances and 3 PMA approvals under its listings, the newest dated August 7, 2025. 16 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006630150
- Address
- 25155 Rye Canyon Loop, Valencia, CA, United States, 91355
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 19, 2007
- Registered through
- 2026
- Brand names listed
- 2x8 Contact Lead Extension Kit, 8 Contact Extension Kit, AC/DC Power Supply, Adhesive Kit, Artisan MRI Surgical Lead Kit, Artisan Surgical Lead Kit, Avista MRI Lead Kit, Base Station and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2025 | K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | GXD | Substantially Equivalent | Boston Scientific Neuromodulation Corporation | accessdata.fda.gov |
| August 23, 2024 | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | GZB | Substantially Equivalent | Boston Scientific Neuromodulation | accessdata.fda.gov |
| October 26, 2022 | K222281 | Intracept Intraosseous Nerve Ablation System | GXI | Substantially Equivalent | Relievant Medsystems, Inc. | accessdata.fda.gov |
| March 11, 2022 | K213836 | Intracept Intraosseous Nerve Ablation System | GXI | Substantially Equivalent | Relievant Medsystems, Inc. | accessdata.fda.gov |
| May 3, 2019 | K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | GXI | Substantially Equivalent | Relievant Medsystems | accessdata.fda.gov |
| March 8, 2019 | K183177 | Nitinol Thermocouple (TCN) Electrode | GXI | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 14, 2018 | K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | GXI | Substantially Equivalent | Relievant Medsystems | accessdata.fda.gov |
| August 18, 2017 | K171143 | Relievant Medsystems RF Generator | GXD | Substantially Equivalent | Relievant Medsystems | accessdata.fda.gov |
| February 23, 2012 | K113805 | FIXATE TISSUE BAND | GZB | Substantially Equivalent | Anulex Technologies, Inc. | accessdata.fda.gov |
| October 16, 2008 | K082051 | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 | GXD | Substantially Equivalent | Cosman Medical, Inc. | accessdata.fda.gov |
| October 14, 2008 | K082012 | COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN | GXI | Substantially Equivalent | Cosman Medical, Inc. | accessdata.fda.gov |
| May 2, 2006 | K060799 | COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA | GXI | Substantially Equivalent | Cosman Medical, Inc. | accessdata.fda.gov |
| March 17, 2005 | K050084 | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; | GXI | Substantially Equivalent | Cosman Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 8, 2017 | P150031 | VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM | NHL | 94 | October 15, 2026 | accessdata.fda.gov |
| May 20, 2015 | P140004 | SUPERION INTERSPINOUS SPACER | NQO | 33 | November 7, 2024 | accessdata.fda.gov |
| April 27, 2004 | P030017 | PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM | LGW | 373 | September 22, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 30, 2026 | 99785 | Not yet classified | Open, Classified | Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System | Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading it to become non-functional, and if a secondary TD is unavailable, this may lead IPG to become non-functional, thus unable to inhibit transmis | accessdata.fda.gov |
| June 17, 2026 | 98974 | Class I | Ongoing | INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems. | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement. | accessdata.fda.gov |
| April 29, 2026 | 98941 | Class II | Ongoing | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Sterile anchors my lack sterility assurance. | accessdata.fda.gov |
| April 29, 2026 | 98939 | Class II | Ongoing | Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, S | Reusable electrodes may not meet expected performance levels. | accessdata.fda.gov |
| April 22, 2026 | 98933 | Class II | Ongoing | Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. | accessdata.fda.gov |
| July 8, 2025 | 97144 | Class II | Ongoing | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth con | accessdata.fda.gov |
| July 8, 2025 | 96916 | Class II | Ongoing | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual | Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery. | accessdata.fda.gov |
| June 6, 2025 | 97109 | Class II | Ongoing | Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 008846 | As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device. | accessdata.fda.gov |
| July 17, 2024 | 94995 | Class II | Ongoing | WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical inter | accessdata.fda.gov |
| April 18, 2024 | 94377 | Class II | Ongoing | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical interventio | accessdata.fda.gov |
| May 12, 2023 | 92181 | Class II | Ongoing | Driver Instrument, part of the Superion Indirect Decompression System, REF:, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual | Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potentia | accessdata.fda.gov |
| October 12, 2022 | 90915 | Class II | Ongoing | Superion Indirect Decompression System (IDS) Model Numbers and Size: - 8mm 01-9812 - 12mm - 14mm | Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation. | accessdata.fda.gov |
| May 30, 2019 | 85085 | Class II | Terminated | Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products. | accessdata.fda.gov |
| April 24, 2019 | 84983 | Class II | Terminated | ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registr | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue. | accessdata.fda.gov |
| July 5, 2017 | 78704 | Class II | Terminated | Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN | After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device. | accessdata.fda.gov |
| March 19, 2010 | 55190 | Not yet classified | Terminated | Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4 | Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Lesion, Radiofrequency
- All makers of Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- All makers of Stimulator, Spinal-Cord, Implanted (Pain Relief)
- All makers of Probe, Radiofrequency Lesion
- All makers of Prosthesis, Spinous Process Spacer/Plate
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
Updated October 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.