FDA.reportPublic FDA data

AGENT™

Primary DI
00191506014698
Brand
AGENT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493960812350
Catalog number
H7493960812350
Device description
Paclitaxel-Coated Balloon Catheter
Published
2024-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OOBDrug-eluting percutaneous transluminal coronary angioplasty catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOBDrug-Eluting Percutaneous Transluminal Coronary Angioplasty CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230035000
P230035006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230035000AGENT Paclitaxel-Coated Balloon CatheterBoston Scientific Corporation2024-02-29OOB
P230035006AGENT Paclitaxel-Coated Balloon CatheterBoston Scientific Corporation2024-02-29OOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506014698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506014698001915060146981915060146980191506014698

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, drug-coatedA flexible tube with a drug coating at its distal end designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate an atherosclerotic stenotic coronary artery by controlled inflation of a distal distensible balloon, and to simultaneously release a drug intended to inhibit restenosis. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. It may be available as an over-the-wire (OTW) or a rapid exchange (RX) type, and devices to assist catheterization may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter3.5Millimeter
Balloon Length12Millimeter

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
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220870068SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870075SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870082SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870099SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870129SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870136SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870143SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870150SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870181SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870198SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870204SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870211SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870242SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870259SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870266SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870273SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870303SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870310SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870327SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870334SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870365SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870372SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870389SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870396SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870426SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870433SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870440SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870457SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870488SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21
00810220870495SELUTION SLR™ 014 PTCA Drug-Eluting BalloonMedalliance, LLCOOB2026-09-21