FDA.reportPublic FDA data

Attain Stability™ Quad MRI SureScan™

Primary DI
00643169860414
Brand
Attain Stability™ Quad MRI SureScan™
Company
MEDTRONIC, INC.
Model
479878
Device description
LEAD 479878 ATTAIN MRI US
Published
2019-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJXDrug eluting permanent left ventricular (lv) pacemaker electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080006129

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080006129MEDTRONIC ATTAIN ABILITY MODEL 4196 LEADMedtronic, Inc.2009-04-07OJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169860414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169860414006431698604146431698604140643169860414

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length78Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature77 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169705753MyCareLink™24950JLQ2016-05-28
00763000354466Symplicity Spyral™RDN0162023-11-30
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414734510196Quartet™ST. JUDE MEDICAL, INC.OJX2025-10-02
04035479138400Sentus ProMRI OTW QP S-75BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138417Sentus ProMRI OTW QP S-85BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138424Sentus ProMRI OTW QP S-95BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138431Sentus ProMRI OTW QP L-75BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138448Sentus ProMRI OTW QP L-85BIOTRONIK SE & Co. KGOJX2019-07-15
04035479138455Sentus ProMRI OTW QP L-95BIOTRONIK SE & Co. KGOJX2019-07-15
04035479145613Sentus ProMRI OTW QP S-95/49BIOTRONIK SE & Co. KGOJX2019-07-15
04035479148966Sentus ProMRI OTW QP L-95/49BIOTRONIK SE & Co. KGOJX2019-07-15
00643169860421Attain Stability™ Quad MRI SureScan™MEDTRONIC, INC.OJX2019-05-26
04035479145590Sentus ProMRI OTW QP S-75/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479145606Sentus ProMRI OTW QP S-85/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479148942Sentus ProMRI OTW QP L-75/49BIOTRONIK SE & Co. KGOJX2017-05-18
04035479148959Sentus ProMRI OTW QP L-85/49BIOTRONIK SE & Co. KGOJX2017-05-18
05414734502603Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734502610Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734502627Quickflex™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734506823SJM™ST. JUDE MEDICAL, INC.OJX2017-04-10
05414734510172Quartet™ST. JUDE MEDICAL, INC.OJX2017-03-30
05414734510189Quartet™ST. JUDE MEDICAL, INC.OJX2017-03-30
00643169860223Attain Ability™ Straight MRI SureScan™MEDTRONIC, INC.OJX2017-03-26
00643169860230Attain Ability™ Straight MRI SureScan™MEDTRONIC, INC.OJX2017-03-26
00643169860025Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860032Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860124Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169860131Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2017-03-24
00643169601765Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601772Attain Ability™ MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601789Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2016-02-26
00643169601796Attain Ability™ Plus MRI SureScan™MEDTRONIC, INC.OJX2016-02-26