FDA.reportPublic FDA data

AGENT™

Primary DI
00191506014674
Brand
AGENT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493960812270
Catalog number
H7493960812270
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
00191506014674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506014674001915060146741915060146740191506014674

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 Diameter2.75Millimeter
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
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16
00191506019648Rubicon™ ControlH749394321813A0H749394321813A02024-02-16
00191506019662Rubicon™ ControlH749394321815A0H749394321815A02024-02-16
00191506019686Rubicon™ ControlH749394321815S0H749394321815S02024-02-16
00191506019709Rubicon™ ControlH749394323506A0H749394323506A02024-02-16
00191506019723Rubicon™ ControlH749394323506B0H749394323506B02024-02-16
00191506019747Rubicon™ ControlH749394323509A0H749394323509A02024-02-16
00191506019761Rubicon™ ControlH749394323509B0H749394323509B02024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506014643AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014650AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014667AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014681AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014698AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014704AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014711AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014728AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014735AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014742AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014759AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014766AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014773AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014780AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014797AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014803AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014810AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014827AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014834AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014841AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014858AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014865AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014872AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014889AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014896AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014902AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21
00191506014919AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21