FDA.reportPublic FDA data

SJM™

Primary DI
05415067027238
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
DRG
Catalog number
MN11350
Device description
Connector Cable Kit
Published
2017-07-24
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
P150004005

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067027238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067027238054150670272385415067027238

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

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
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067032195EnSite™ENSITE-FF-01ENSITE-FF-012021-01-06
05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
05415067024732EnSite Precision™H702473H7024732020-07-22
05415067024695EnSite Precision™H702469H7024692016-12-20
05415067024701EnSite Precision™H702470H7024702016-12-20
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
05415067054661TactiSys™TSQ-V1.8-TFDM-01TSQ-V1.8-TFDM-012026-08-19
05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03

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
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
05415067025494Axium™ST. JUDE MEDICAL, INC.PMP2016-03-29