FDA.reportPublic FDA data

Microny™

Primary DI
05414734006224
Brand
Microny™
Company
ST. JUDE MEDICAL, INC.
Model
2525T
Catalog number
2525T
Device description
Pulse GeneratorSSIR
Published
2017-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWOPulse-generator, single chamber, sensor driven, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWOPulse-Generator, Single Chamber, Sensor Driven, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970013036
P970013081

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970013036MICRONY PACEMAKERSABBOTT MEDICAL2000-12-21LWO
P970013081MICRONY PACEMAKERSABBOTT MEDICAL2000-12-21LWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734006224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734006224054147340062245414734006224

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable pacemaker, rate-responsiveA sterile, 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5.9Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 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.LWO2025-06-25
05415067050045Neutrino™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWO2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWO2024-11-13
05415067031914Aveir™ST. JUDE MEDICAL, INC.LWO2023-03-03
05415067034472Aveir™ST. JUDE MEDICAL, INC.LWO2023-03-03
05415067036384Aveir™ST. JUDE MEDICAL, INC.LWO2023-03-03
05415067040404NAST. JUDE MEDICAL, INC.LWO2023-01-09
05415067031174Merlin™ST. JUDE MEDICAL, INC.LWO2022-08-29
05415067037121Merlin™ST. JUDE MEDICAL, INC.LWO2022-08-29
05414734509732Merlin.netST. JUDE MEDICAL, INC.LWO2016-05-04
05414734509725Merlin™ST. JUDE MEDICAL, INC.LWO2016-01-27
05414734504782Merlin@home™ST. JUDE MEDICAL, INC.LWO2015-01-19
05414734504799Merlin@home™ST. JUDE MEDICAL, INC.LWO2015-01-19