FDA.reportPublic FDA data

ELUVIA™

Primary DI
08714729876632
Brand
ELUVIA™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939294700470
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
08714729876632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729876632087147298766328714729876632

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
Length75Centimeter
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
00191506063146OPAL HDx™M004OPAL65110M004OPAL651102026-10-30
00191506063153OPAL HDx™M004OPAL63020M004OPAL630202026-10-30
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14
08714729840503SYNERGY™H7493926112220H74939261122202016-01-14
08714729840510SYNERGY™H7493926112250H74939261122502016-01-14
08714729840527SYNERGY™H7493926112270H74939261122702016-01-14
08714729840534SYNERGY™H7493926112300H74939261123002016-01-14
08714729840541SYNERGY™H7493926112350H74939261123502016-01-14
08714729840558SYNERGY™H7493926112400H74939261124002016-01-14
08714729840565SYNERGY™H7493926116220H74939261162202016-01-14
08714729840572SYNERGY™H7493926116250H74939261162502016-01-14
08714729840589SYNERGY™H7493926116270H74939261162702016-01-14
08714729840596SYNERGY™H7493926116300H74939261163002016-01-14
08714729840602SYNERGY™H7493926116350H74939261163502016-01-14

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
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