FDA.reportPublic FDA data

NA

Primary DI
08714729896104
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
DB-4254
Device description
35cm Long Tunneling Tool
Published
2017-12-15
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
MHYStimulator, electrical, implanted, for parkinsonian tremor
NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
PJSStimulator, electrical, implanted, for essential tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150031000
P150031028
P150031040
P150031064
P150031082

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
08714729896104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729896104087147298961048714729896104

GMDN Terms#

Term, Definition table
TermDefinition
Deep brain electrical stimulation systemAn assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
08714729764465Precision ™SC-5312SC-53122015-10-10
08714729779902Artisan™SC-8216-502015-12-14
08714729779919Artisan™SC-8216-702015-12-14
08714729821243Precision™SC-6412-32015-12-14
08714729121688Precision ™SC-6350SC-63502015-08-20
08714729767589NASC-43202015-11-09
00191506070564NANM-7174M365NM717402026-06-08
00191506070595NADB-7174M365DB717402026-06-08
08714729789550Linear™ 3-4SC-2352-502015-12-15
08714729789574Linear™ 3-6SC-2366-502015-12-15
08714729789659Linear™ 3-6SC-2366-302015-12-14
08714729896098NADB-42522017-12-15
08714729896111NADB-4100A2017-12-15
08714729931751NADB-43202017-12-12
08714729965848Vercise™DB-64125-US2017-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.NHL2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.MHY2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.NHL2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.PJS2026-08-07
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
00199150017850N/AMEDTRONIC, INC.MHY2026-02-05
00199150017850N/AMEDTRONIC, INC.NHL2026-02-05
00199150006045N/AMEDTRONIC, INC.NHL2026-02-02
00199150006045N/AMEDTRONIC, INC.PJS2026-02-02
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15