FDA.reportPublic FDA data

WALLSTENT™ RP Endoprosthesis

Primary DI
08714729345756
Brand
WALLSTENT™ RP Endoprosthesis
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001712190
Catalog number
M001712190
Device description
Self-Expanding Stent
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIOSTENT, ILIAC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIOStent, IliacUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P940019000
P940019002
P940019003
P940019004
P940019005
P940019008
P940019009
P940019010
P940019011
P940019016
P940019019
P940019021
P940019025

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P940019000WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019002WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019003WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019004WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019005WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019008WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019009WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019010WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019011WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019016WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019019WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019021WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO
P940019025WALLSTENT(R) ILIAC ENDOPROSTHESISBoston Scientific Scimed, Inc.1996-05-28NIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729345756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729345756087147293457568714729345756

GMDN Terms#

Term, Definition table
TermDefinition
Iliac artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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