FDA.reportPublic FDA data

AGENT™

Primary DI
00191506014803
Brand
AGENT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493960820250
Catalog number
H7493960820250
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
00191506014803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506014803001915060148031915060148030191506014803

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 Diameter2.5Millimeter
Balloon Length20Millimeter

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
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
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

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
00191506014674AGENT™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
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