FDA.reportPublic FDA data

SJM™

Primary DI
05414734402323
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
3383
Catalog number
3383
Published
2015-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734402323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734402323054147344023235414734402323

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic spinal cord electrical stimulation systemAn assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal150 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit
Special Storage Condition, Specify00KEEP DRY
Storage Environment Atmospheric Pressure70 KiloPascal150 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150033478NAMEDTRONIC, INC.LGW2026-03-02
05415067054111N/AADVANCED NEUROMODULATION SYSTEMS, INC.LGW2026-03-02
05415067055842Proclaim™ADVANCED NEUROMODULATION SYSTEMS, INC.LGW2026-02-13
00763000984687Inceptiv™MEDTRONIC, INC.LGW2025-06-19
05415067051882NAADVANCED NEUROMODULATION SYSTEMS, INC.LGW2025-04-09
04035479185817Neuro CP app 2300.UBIOTRONIK SE & Co. KGLGW2025-03-27
04035479188733Neuro PR app 2400.UBIOTRONIK SE & Co. KGLGW2025-03-27
00763000964153Vanta™ AdaptiveStim™MEDTRONIC, INC.LGW2025-03-20
00813426020824Nevro®NEVRO CORP.LGW2025-02-28
00813426020831Nevro®NEVRO CORP.LGW2025-02-28
00813426020848Nevro®NEVRO CORP.LGW2025-02-28
00813426020879Nevro®NEVRO CORP.LGW2025-02-28
00813426020886Nevro®NEVRO CORP.LGW2025-02-28
00813426021098SenzaNEVRO CORP.LGW2025-02-28
00813426021104SenzaNEVRO CORP.LGW2025-02-28
05415067051905NAADVANCED NEUROMODULATION SYSTEMS, INC.LGW2025-01-24
09352307001800Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2024-12-13
09352307001909Evoke® Clarity® Programming Application SALUDA MEDICAL PTY LIMITEDLGW2024-12-13
00197513012016TABLEPADBURLINGTON MEDICAL, LLCLGW2024-10-21
00643169955653N'VISION®MEDTRONIC, INC.LGW2024-10-04
00763000922382N/AMEDTRONIC, INC.LGW2024-05-24
00763000849078Vanta™ AdaptiveStim™MEDTRONIC, INC.LGW2024-05-19
00763000852887Injex®MEDTRONIC, INC.LGW2024-05-19
00763000852894Injex®MEDTRONIC, INC.LGW2024-05-19
00813426021067SenzaNEVRO CORP.LGW2024-05-08
00763000586850N/AMEDTRONIC, INC.LGW2024-05-06
00763000849047Intellis™ AdaptiveStim™MEDTRONIC, INC.LGW2024-05-06
00763000287306N/AMEDTRONIC, INC.LGW2024-05-05
00763000371463N/AMEDTRONIC, INC.LGW2024-05-05
00763000371470N/AMEDTRONIC, INC.LGW2024-05-05