FDA.reportPublic FDA data

Verity™

Primary DI
05414734006774
Brand
Verity™
Company
ST. JUDE MEDICAL, INC.
Model
ADx XL SR
Catalog number
5157M/S
Device description
Pulse Generator SSIR
Published
2017-02-03
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
KRGProgrammer, pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRGProgrammer, PacemakerCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880086094
P880086304
P880086307

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880086094ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY
P880086304ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY
P880086307ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734006774PrimaryGS10
H7585157MS0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734006774054147340067745414734006774

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 Volume11Milliliter

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
04035479001575M-50BIOTRONIK SE & Co. KGKRG2024-10-16
00763000842536NAMEDTRONIC, INC.KRG2023-11-11
20763000842530NAMEDTRONIC, INC.KRG2023-11-11
00763000181185NAMEDTRONIC, INC.KRG2023-01-30
04035479176112DataBridge NABIOTRONIK SE & Co. KGKRG2022-12-14
00763000059545Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059651Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00763000059668Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-10-21
00643169720138Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720145Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720190Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720206Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720251Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720268Viva™ S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720312Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169720329Viva™ S CRT-DMEDTRONIC, INC.KRG2017-09-15
00643169929319Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929371Viva™ S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929388Viva™ S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929395Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-05-22
00643169929296Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929302Viva™ XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929326Viva™ Quad XT CRT-DMEDTRONIC, INC.KRG2017-05-14
00643169929401Viva™ Quad S CRT-DMEDTRONIC, INC.KRG2017-05-14
05414734500449SJM™ST. JUDE MEDICAL, INC.KRG2017-04-10
05414734006880Identity™ST. JUDE MEDICAL, INC.KRG2017-02-06
05414734006811Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006835Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006842Verity™ST. JUDE MEDICAL, INC.KRG2017-02-03
05414734006866Integrity™ST. JUDE MEDICAL, INC.KRG2017-02-03