FDA.report

Boston Scientific Neuromodulation Corporation

Matched from indexed company URL: Boston Scientific Neuromodulation

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30066301503006630150Boston Scientific Neuromodulation Corporation1N2026-01-0125155 Rye Canyon Loop Valencia CA US 91355

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
786741401702589P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL2017-12-08
786741730363118P140004SUPERION INTERSPINOUS SPACERNQO2015-05-20
786741259418821P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMLGW2004-04-27
786741403031099K251247GX1 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)GXD2025-08-07
786741708004881K222281Intracept Intraosseous Nerve Ablation SystemGXI2022-10-26
786741287126463K213836Intracept Intraosseous Nerve Ablation SystemGXI2022-03-11
786741605651715K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF GeneratorGXI2019-05-03
786741263951568K183177Nitinol Thermocouple (TCN) ElectrodeGXI2019-03-08
786741764785425K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)GXI2018-09-14
786741955963636K171143Relievant Medsystems RF GeneratorGXD2017-08-18
786741312469695K113805FIXATE TISSUE BANDGZB2012-02-23
786741600543159K101131FIDUCIAL MARKERSIYE2010-06-17
786741396992525K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4GXD2008-10-16
786741163661411K082012COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CNGXI2008-10-14
786741864581900K060799COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULAGXI2006-05-02
786741225760944K050084COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;GXI2005-03-17
786741975732047

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GXI82022-10-26
GXD32025-08-07
NHL12017-12-08
NQO12015-05-20
GZB12012-02-23
IYE12010-06-17
LGW12004-04-27

PMA

Superion Indirect Decompression System

2023-01-06

Boston Scientific Neuromodulation25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP140004 Supplement NumberS029 Date Received12/08/2022 Decision Date01/06/2023 Product Code NQO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason P...

Vertiflex Instrument Platform (VIP) Kit

2022-03-02

Boston Scientific Neuromodulation25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP140004 Supplement NumberS028 Date Received12/03/2021 Decision Date03/02/2022 Product Code NQO  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reas...

PMN

GUDID

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