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
2024-08-23
GZB
2022-06-10
Nalu Neurostimulation System
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GZB
2021-03-25
Nalu Neurostimulation System
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GZB
2020-11-09
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
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GZB
2020-07-15
Nalu Neurostimulation SCS system
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GZB
2019-11-07
SandShark Injectable Anchor (SIA) System
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GZB
2019-07-11
Nalu Lead Blank (50cm)
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GZB
2019-03-29
Freedom Spinal Cord Stimulator (SCS) System
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GZB
2019-03-22
Nalu Neurostimulation System
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GZB
2018-09-19
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
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GZB
2017-11-03
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
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GZB
2017-05-02
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
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GZB
2016-12-16
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
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GZB
2016-08-26
Freedom Spinal Cord Stimulator System
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GZB
2013-06-18
MULTI LEAD TRIAL CABLE
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GZB
2013-01-18
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
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GZB
2012-04-20
RAPID PROGRAMMER
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GZB
2012-02-23
FIXATE TISSUE BAND
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GZB
2011-12-16
FIXATE TISSUE BAND
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GZB
2011-11-17
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
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GZB
2011-10-27
FIXATE TISSUE BAND
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GZB
2011-09-08
FIXATE TISSUE BAND
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GZB
2010-10-26
MULTI-LEAD TRIALING CABLE MODEL 355531
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GZB
2009-12-23
SWIFT-LOCK ANCHOR, MODEL 1192
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GZB
2009-07-31
RAPID PROGRAMMER, VERSION 3.3.0
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GZB
2009-06-02
PENTA LEAD KITS, MODELS: 3227-3234
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GZB
2008-07-18
CINCH ANCHOR, MODEL 1194
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GZB
2007-10-11
WIDE SPACED QUATTRODE LEADS
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GZB
2007-04-11
TRIAL CABLE, 3009
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GZB
2006-12-12
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
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GZB
2006-08-16
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
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GZB
2005-12-15
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
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GZB
2005-11-22
RAPID PROGEAMMER 3.0
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GZB
2005-09-26
AXXESS BUTTERFLY ANCHOR
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GZB
2005-07-28
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
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GZB
2005-05-18
ANS SCS ACCESSORY KIT
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GZB
2005-04-21
TRIAL CABLE RETENTION CLIP
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GZB
2004-03-25
RAPID PROGRAMMER
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GZB
2004-03-25
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
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GZB
2004-01-30
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
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GZB
2003-12-04
LAMITRODE SPINAL CORD STIMULATION LEADS
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GZB
2003-10-30
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
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GZB
2003-10-06
MODIFICATION TO RENEW LEAD EXTENSION
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GZB
2003-10-03
PLACER
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GZB
2003-10-03
ANS AXXESS PERCUTANEOUS LEAD
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GZB
2003-09-11
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
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GZB
2003-04-24
A127 LEAD EXTENSION
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GZB
2003-03-28
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
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GZB
2003-03-11
RAPID PROGRAMMAR
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GZB
2002-08-08
LAMITRODE S-SERIES (S4 AND S8) LEADS
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GZB
2002-06-06
PAINDOC
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GZB
2002-01-24
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
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GZB
2001-12-11
GRIP LOCK ANCHOR, MODEL 411374
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GZB
2001-08-01
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
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GZB
2001-07-16
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
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GZB
2001-06-22
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
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GZB
2000-04-28
MEDTRONIC MODEL 7499 EXTENSION
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GZB
2000-03-01
MEDAMICUS EPIDURAL INTRODUCER
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GZB
1999-09-24
RENEW RECEIVER
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GZB
1999-06-24
RENEW LEAD EXTENSION
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GZB
1999-06-03
LAMITRODE LEADS
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GZB
1999-02-09
MEDTRONIC MODEL 7495 EXTENSION KIT
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GZB
1998-02-06
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
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GZB
1998-02-03
MEDTRONIC MODEL 3998 LEAD
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GZB
1997-08-22
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
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GZB
1997-07-03
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
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GZB
1996-11-19
BIFURCATED Y-EXTENSION
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GZB
1996-05-22
ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
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GZB
1996-05-17
DUALSCREEN
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GZB
1995-11-27
MODEL NOS. 7495 AND 501826 EXTENSIONS
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GZB
1995-10-13
PAIN DOC
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GZB
1995-08-30
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
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GZB
1995-04-12
MODEL 3470 X-TREL RF RECEIVER
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GZB
1995-02-14
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
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GZB
1995-01-30
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
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GZB
1995-01-11
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
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GZB
1994-12-15
NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
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GZB
1994-12-12
NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
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GZB
1994-07-18
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
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GZB
1994-07-11
NEUROLOGICAL LEAD ACCESSORIES
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GZB
1994-06-14
TEMPORARY SCREENING LEAD/CATHETER KIT
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GZB
1994-05-04
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
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GZB
1994-02-03
MEDTRONIC MODEL 3625 SCREENER SYSTEM
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GZB
1994-02-02
INTRODE INT-8
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GZB
1993-05-05
NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
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GZB
1993-03-18
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
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GZB
1993-03-18
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
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GZB
1992-11-05
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
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GZB
1992-07-07
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
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GZB
1992-02-07
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
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GZB
1992-01-22
MEDTRONIC MODEL 3586 RESUME LEAD
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GZB
1991-12-23
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
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GZB
1991-11-22
MEDTRONIC 3625 SCREENER SYSTEM
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GZB
1991-11-22
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
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GZB
1991-06-27
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
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GZB
1991-03-11
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
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GZB
1991-03-11
ANTIGENZ CHLAMYDIA
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GZB
1991-02-14
MEDTRONIC (R) MODEL 3625 SCREENER
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GZB
1991-02-11
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
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GZB
1991-02-01
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
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