Stimulator, Spinal-Cord, Implanted (Pain Relief)

FDA product code GZB · 135 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5880
Review panel: NE
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-01-17 – 2024-08-23

GZB 1991-01-25

NEUROMED MODEL 1992 LS LAMITRODE LEAD

Applicant Neuromed, Inc.

K number K905255

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GZB 1991-01-16

NEUROMED TS8 TEST STIMULATOR

Applicant Neuromed, Inc.

K number K903814

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GZB 1990-06-29

NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.

Applicant Neuromed, Inc.

K number K901499

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GZB 1990-04-30

MODEL 3586 RESUME LEAD

Applicant Medtronic Vascular

K number K890061

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GZB 1989-08-07

MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION

Applicant Medtronic Vascular

K number K892884

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GZB 1989-01-17

MODEL 3487A PISCES EPIDURAL LEAD

Applicant Medtronic Vascular

K number K885033

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GZB 1989-01-17

MODEL 3587A RESUME EPIDURAL LEAD

Applicant Medtronic Vascular

K number K884948

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GZB 1988-11-30

XTREL, MODEL NUMBER 3425

Applicant Medtronic Vascular

K number K883780

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GZB 1988-05-25

MODEL 3487A PISCES EPIDURAL LEAD

Applicant Medtronic Vascular

K number K881491

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GZB 1987-10-06

MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD

Applicant Medtronic Vascular

K number K873675

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GZB 1986-10-06

MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)

Applicant Neuromed, Inc.

K number K862915

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GZB 1986-05-09

MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT

Applicant Medtronic Vascular

K number K855107

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GZB 1986-04-04

UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER

Applicant Neuromed, Inc.

K number K860185

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GZB 1986-03-07

8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR

Applicant Neuromed, Inc.

K number K860158

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GZB 1985-11-14

MULTISTIM LAMINECTOMY ELECTRODE

Applicant Neuromed, Inc.

K number K853643

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GZB 1985-11-14

UNISTIM UNT-1

Applicant Neuromed, Inc.

K number K852326

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GZB 1985-10-10

QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF

Applicant Neuromed, Inc.

K number K852920

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GZB 1985-08-14

CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A

Applicant Cordis Corp.

K number K852827

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GZB 1985-02-06

MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL

Applicant Medtronic Vascular

K number K844115

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GZB 1984-05-14

MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL

Applicant Medtronic Vascular

K number K841584

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GZB 1984-03-19

SPINAL CORD STIMULATION SYS SE-4

Applicant Medtronic Vascular

K number K833990

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GZB 1983-12-01

NEURAL STIMULATOR MONITOR

Applicant Instromedix, Inc.

K number K833809

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GZB 1983-08-11

PISCES #3487 EPIDURAL LEAD FOR SPINAL

Applicant Medtronic Vascular

K number K831746

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GZB 1982-12-15

STIMUCORD EXTERNAL NEURAL STIM. 911A

Applicant Cordis Corp.

K number K823530

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GZB 1982-06-23

MEDTRONIC #1992-2 DUAL RATE TRANSMITTER

Applicant Medtronic Vascular

K number K820988

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GZB 1981-10-08

MEDTRONIC DUAL CHANNEL SPINAL CORD STIM

Applicant Medtronic Vascular

K number K812155

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GZB 1981-08-20

MEDTRONIC #3484 PISCES EPIDURAL LEAD

Applicant Medtronic Vascular

K number K812154

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GZB 1981-07-01

MYELOSTAT DORSAL CORD STIMULATOR

Applicant Medtronic Vascular

K number K811655

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GZB 1981-04-03

PROGRAMMABLE SPINAL CORAL STIM. SYSTEM

Applicant Electronic Diagnostics, Inc.

K number K810182

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GZB 1981-02-19

CORDIS STIMUCORD EXTERNAL NEUTRAL STIM

Applicant Cordis Corp.

K number K810319

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GZB 1980-07-08

MYELOSTAT DORSAL CORD STIMULATOR, ETC.

Applicant Medtronic Vascular

K number K801384

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GZB 1980-02-05

MEDTRONIC PISCES GENERATION II LEAD KIT

Applicant Medtronic Vascular

K number K800193

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GZB 1979-05-25

PISCES-SELECTOR X

Applicant Medtronic Vascular

K number K790790

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GZB 1978-05-19

NEUROLOGICAL SCREENING STIMULATOR M 3623

Applicant Medtronic Vascular

K number K780758

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GZB 1978-01-17

EPIDURAL LEAD - MODEL 3481

Applicant Medtronic Vascular

K number K780001

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