FDA.reportPublic FDA data

NA

Primary DI
08714729121411
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
SC-4100A
Device description
OR Cable and Extension
Published
2015-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MHYStimulator, electrical, implanted, for parkinsonian tremor
NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
PJSStimulator, electrical, implanted, for essential tremor
QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030017000
P030017270
P030017357
P030017363
P030017382
P150031000
P150031028
P150031040
P150031064
P150031082

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030017000PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017270PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017357PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017363PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P030017382PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMBoston Scientific Corp2004-04-27LGW
P150031000VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL
P150031028VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL
P150031040VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL
P150031064VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL
P150031082VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMBoston Scientific Corp2017-12-08NHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729121411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729121411087147291214118714729121411

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824951958
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729792857NASC-6358-9BKM365SC63589BK02015-08-20
08714729121688Precision ™SC-6350M365SC635002015-08-20
08714729820987NANM-6350M365NM635002017-12-15
08714729989301NADB-6358-9BKM365DB63589BK02021-01-28
08714729767817Precision ™ OMG™SC-9305SC-93052015-10-10
08714729767824Precision ™ OMG™SC-9310SC-93102015-10-10
08714729861546Precision Spectra™ OMGSC-9315SC-93152015-08-20
08714729832669CoverEdge™ 32SC-8336-502015-12-14
08714729832676CoverEdge™ 32SC-8336-702015-12-14
08714729832683CoverEdge™ X 32SC-8352-502015-12-14
08714729832690CoverEdge™ X 32SC-8352-702015-12-14
08714729837213NASC-4231-362015-11-09
08714729837220NASC-4231-522015-11-09
08714729792833NANM-6358-SPNM-6358-SP2015-08-20
08714729952145Vercise™DB-93152019-01-15
08714729767534Precision™SC-9004-352015-12-14
08714729767541Precision™SC-9004-552015-12-14
08714729767558Precision™SC-9004-702015-12-14
08714729791973Clik™ AnchorSC-42762015-11-09
08714729793267Click™SC-43162015-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.MHY2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.NHL2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.NHL2026-08-07
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
00763000520083N/AMEDTRONIC, INC.QRB2021-07-23
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
08714729989301NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2021-01-28
08714729989301NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-01-28
08714729989301NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729952145Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2019-01-15
08714729952145Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2019-01-15