FDA.reportPublic FDA data

Zenex MRI™

Primary DI
05415067055507
Brand
Zenex MRI™
Company
ST. JUDE MEDICAL, INC.
Model
PM1283
Catalog number
PM1283
Device description
SR Pacemaker
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWPImplantable pulse generator, pacemaker (non-CRT)
NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140033100

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140033100Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareABBOTT MEDICAL2017-01-31LWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067055507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067055507054150670555075415067055507

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable pacemaker, rate-responsiveA battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry, keep away from sunlight, Protect from heat and radioactive sources
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
Serial number
true
Expiration 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
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWP2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWP2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWP2024-11-13
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
05415067040404NAST. JUDE MEDICAL, INC.LWP2023-01-09
00763000740252SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
00763000740276SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWP2022-08-29
00763000316778Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316785Adapta™MEDTRONIC, INC.LWP2020-11-28
00763000316808Attesta™ DR MRI SureScan™MEDTRONIC, INC.LWP2020-07-30
00763000316822Attesta™ S DR MRI SureScan™MEDTRONIC, INC.LWP2020-07-30
00763000130794SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
00763000130817SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
00643169634626Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2017-12-02
00643169871953Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2017-11-02
00643169410961CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26
00643169448940CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVN2017-10-26