FDA.reportPublic FDA data

Assurity™

Primary DI
05414734507066
Brand
Assurity™
Company
ST. JUDE MEDICAL, INC.
Model
PM1240
Catalog number
PM1240
Device description
SR Pacemaker SSIR
Published
2017-04-10
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
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880086230
P880086267
P880086276
P880086279
P880086280
P880086304
P880086307

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880086230ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY
P880086267ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY
P880086276ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY
P880086279ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSABBOTT MEDICAL1989-08-21DXY
P880086280ACCENT, 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
05414734507066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734507066054147345070665414734507066

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 Volume10.4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
00763000612658MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
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00763000316792Adapta™MEDTRONIC, INC.NVZ2020-11-28