FDA.reportPublic FDA data

Axium™

Primary DI
05415067025593
Brand
Axium™
Company
ST. JUDE MEDICAL, INC.
Model
MN10700
Catalog number
MN10700
Device description
Clinical Programmer Kit
Published
2016-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
05415067025593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067025593054150670255935415067025593

GMDN Terms#

Term, Definition table
TermDefinition
Implantable spinal cord electrical stimulation system programmerA battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity93 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 Humidity0 Percent (%) Relative Humidity93 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
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
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
05415067054111N/AADVANCED NEUROMODULATION SYSTEMS, INC.PMP2026-03-02
05415067055880Proclaim™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2026-02-13
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