FDA.reportPublic FDA data

Integrity

Primary DI
00613994798541
Brand
Integrity
Company
MEDTRONIC, INC.
Model
INT35009UX
Device description
Stent INT35009UX INTEGRITY 3.50X09UX
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAFSTENT, CORONARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAFStent, CoronaryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030009039
P030009092
P030009097

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030009039DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMSMedtronic, Ireland2003-10-01MAF
P030009092DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMSMedtronic, Ireland2003-10-01MAF
P030009097DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMSMedtronic, Ireland2003-10-01MAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994798541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994798541006139947985416139947985410613994798541

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal coronary artery stentA non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894588002125Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002132Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002149Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002156Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002163Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002170Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002187Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
10705032064736PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076197PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076234PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076241PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
20705032057285PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057261PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057247PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057346PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
10705032076227PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-04-29
20705032057223PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-04-29
08714729203940WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203957WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203964WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203971WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203988WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203995WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204008WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204015WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204022WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204039WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204046WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204053WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729406433WALLSTENT™ RP EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24