FDA.reportPublic FDA data

Precision™

Primary DI
08714729121480
Brand
Precision™
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
SC-4310
Device description
Suture Sleeve 4cm Segmented
Published
2015-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030017000
P030017357
P030017363
P030017382

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030017000PRECISION 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729121480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729121480087147291214808714729121480

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation lead suture sleeveA small device with a hollow centre that functions as a channel for an implantable electrical stimulation lead (e.g., pacing lead, defibrillation lead, neurostimulation lead) intended to be positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the electrical stimulator, pacemaker or defibrillator system.

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
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
08714729896104NADB-42542017-12-15
08714729896111NADB-4100A2017-12-15
08714729931751NADB-43202017-12-12
08714729965848Vercise™DB-64125-US2017-12-12
08714729121466Precision™SC-43002015-11-09
08714729121473Precision™SC-43052015-11-09
08714729767572Precision ™SC-42302015-11-09
08714729767626Precision™SC-43062015-11-09
08714729767756Precision™SC-43012015-11-09
08714729767763Precision™SC-43112015-11-09
08714729888734Precision™SC-9218-152015-12-14
08714729888758Precision™SC-9218-552015-12-14
08714729893271Precision™SC-9208-152015-12-14
08714729893288Precision™SC-9208-552015-12-14
08714729767725Linear™ STSC-2218-502015-12-14
08714729767749Linear™ STSC-2218-702015-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729985082WaveWriter Alpha™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2020-12-28
08714729982579Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2019-05-24
08714729978404Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2018-05-11
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729970606Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-01-16
08714729960713NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-08-15
08714729960720NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-08-15
08714729951124Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729951131Artisan™ MRIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-06
08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
08714729951254Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952046Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953432Spectra WaveWriter™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729952053Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953449Freelink™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729953487Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935124NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935179NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935186NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729937395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935087Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935094Bionic Navigator™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729821502NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729954385NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14
08714729954392NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2017-04-14