FDA.reportPublic FDA data

Implantable electrical stimulation system intraoperative test lead

Definition
A flexible wire intended to be used during open surgical implantation of an electrical stimulation system, and designed to conduct electrical impulses from an external (nonimplantable) pulse generator to the implantable electrode prior to full system implantation to ensure the electrode is positioned correctly, through intraoperative observation of the desired nerve response. This is a single-use device.
GUDID devices
32
Last updated
2026-08-28 10:23:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08714729767817Precision ™ OMG™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-93052015-10-10
08714729767824Precision ™ OMG™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-93102015-10-10
08714729837213NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-4231-362015-11-09
08714729837220NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-4231-522015-11-09
08714729861546Precision Spectra™ OMGBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-93152015-08-20
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.12006-060-US2020-04-21
00812537031026Nalu Medical, Inc.NALU MEDICAL, INC.72003-US2019-06-01
00812537031934Nalu Medical, Inc.NALU MEDICAL, INC.12006-060-US2019-06-01
00812537032313Nalu Medical, Inc.NALU MEDICAL, INC.23013-050-US2019-09-23
00812537034614Nalu Medical, Inc.NALU MEDICAL, INC.12006-0602020-04-21
00812537035222Nalu Medical, Inc.NALU MEDICAL, INC.12006-060-US2020-04-20
10812537030071Nalu Medical, Inc.NALU MEDICAL, INC.12006-060-US2020-04-21
10812537030224Nalu Medical, Inc.NALU MEDICAL, INC.23013-050-US2020-04-21
10812537034611Nalu Medical, Inc.NALU MEDICAL, INC.12006-0602020-04-21
08714729767572Precision ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-42302015-11-09
00850075633043Neuspera SNM SystemNeuSpera Medical Inc.TLK-12025-11-17
00850075633098Neuspera SNM SystemNeuSpera Medical Inc.TL-12025-11-17
00850075633418Neuspera SNM SystemNeuSpera Medical Inc.ELK-12025-11-17
08714729784067Linear™ STBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-2218-50E2015-12-14
08714729784074Linear™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-2158-50E2015-12-14
08714729820741Linear™ STBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-2218-70E2015-12-14
08714729888741Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-9218-15E2015-12-14
08714729888765Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-9218-55E2015-12-14
08714729893295Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-9208-15E2015-12-14
08714729893301Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-9208-55E2015-12-14
08714729861621Infinion™ CXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-2317-50E2015-12-14
08714729861645Infinion™ CXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-2317-70E2015-12-14
08714729995814CoverEdge™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-8436-502020-12-28
08714729995821CoverEdge™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-8436-702020-12-28
08714729995838CoverEdge™ X MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-8452-502020-12-28
08714729995845CoverEdge™ X MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSC-8452-702020-12-28
10810005340127AxonicsAXONICS MODULATION TECHNOLOGIES, INC.19012019-09-23