Axium™

Primary DI
05415067025500
Brand
Axium™
Company
ST. JUDE MEDICAL, INC.
Model
MN10200
Catalog number
MN10200
Device description
Implantable Neurostimulator Kit
Published
2016-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMPDorsal root ganglion stimulator for pain relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMPDorsal Root Ganglion Stimulator For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150004000
P150004005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150004000Axium Neurostimulator SystemABBOTT MEDICAL2016-02-11PMP
P150004005Axium Neurostimulator SystemABBOTT MEDICAL2016-02-11PMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067025500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067025500054150670255005415067025500

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit122 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
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05415067018533SJM™121312132015-07-29
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05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415067053060NAADVANCED NEUROMODULATION SYSTEMS, INC.PMP2025-12-07
05415067050311NeuroSphere™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2025-01-17
05415067046956NeuroSphere™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046376Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046383Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046390Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046406Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046970NeuroSphere™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067027122NAST. JUDE MEDICAL, INC.PMP2017-11-16
05415067027863NAST. JUDE MEDICAL, INC.PMP2017-11-16
05415067029072NAADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-11-16
05415067027238SJM™ST. JUDE MEDICAL, INC.PMP2017-07-24
05415067027139SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027146SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027153SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027160SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027177NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027191NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027207NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027214NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027221NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027184NAST. JUDE MEDICAL, INC.PMP2017-05-24
05415067027337Axium™SPINAL MODULATION, INC.PMP2017-05-24
05415067027344Axium™SPINAL MODULATION, INC.PMP2017-05-24
05415067026996NAST. JUDE MEDICAL, INC.PMP2017-03-23
05415067020215Proclaim™ST. JUDE MEDICAL, INC.PMP2017-03-23
15415067026993NAST. JUDE MEDICAL, INC.PMP2017-03-23
05415067027313Proclaim™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-03-23