FDA.reportPublic FDA data

ELUVIA™

Primary DI
08714729876731
Brand
ELUVIA™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939294701210
Device description
Drug-Eluting Vascular Stent System
Published
2018-10-10
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
P180011000
P180011011
P180011025
P180011028
P180011046
P180011052
P180011055

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180011000Eluvia Drug-Eluting Vascular Stent SystemBoston Scientific Corp2018-09-18NIU
P180011011Eluvia Drug-Eluting Vascular Stent SystemBoston Scientific Corp2018-09-18NIU
P180011025Eluvia Drug-Eluting Vascular Stent SystemBoston Scientific Corp2018-09-18NIU
P180011028Eluvia Drug-Eluting Vascular Stent SystemBoston Scientific Corp2018-09-18NIU
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
08714729876731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729876731087147298767318714729876731

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting femoral artery stentA non-bioabsorbable metal tubular mesh structure with a drug coating intended to be implanted, via a delivery catheter, into the superficial femoral artery 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 may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length120Millimeter
Length130Centimeter
Outer Diameter7Millimeter

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
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

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
08714729876687ELUVIA™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
10827002384832Zilver PTXCOOK IRELAND LTDNIU2018-02-27