FDA.reportPublic FDA data

ELUVIA™

Primary DI
08714729876687
Brand
ELUVIA™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939294701570
Catalog number
H74939294701570
Device description
Drug-Eluting Vascular Stent System
Published
2022-07-15
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
NIUStent, superficial femoral artery, drug-eluting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIUStent, Superficial Femoral Artery, Drug-ElutingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180011046
P180011052
P180011055

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180011046Eluvia Drug-Eluting Vascular Stent SystemBoston Scientific Corp2018-09-18NIU
P180011052Eluvia Drug-Eluting Vascular Stent SystemBoston Scientific Corp2018-09-18NIU
P180011055Eluvia Drug-Eluting Vascular Stent SystemBoston Scientific Corp2018-09-18NIU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729876687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729876687087147298766878714729876687

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting peripheral artery stent, bare-metalA non-bioabsorbable metal tubular mesh structure with a drug coating intended to be implanted, into a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to maintain luminal patency typically in patients with symptomatic peripheral artery disease. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation (e.g., delivery catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length75Centimeter
Stent Diameter7Millimeter
Stent Length150Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729876564ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2022-07-15
08714729876625ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2022-07-15
08714729876748ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2022-07-15
10827002384047Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384078Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384085Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384146Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384153Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384160Zilver PTXCOOK IRELAND LTDNIU2018-12-13
08714729876519ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876526ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876533ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876540ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876557ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876571ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876588ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876595ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876601ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876618ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876632ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876649ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876656ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876663ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876670ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876694ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876700ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876717ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876724ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876731ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
10827002384832Zilver PTXCOOK IRELAND LTDNIU2018-02-27