FDA.reportPublic FDA data

AGENT™

Primary DI
00191506014902
Brand
AGENT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493960830350
Catalog number
H7493960830350
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
00191506014902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506014902001915060149021915060149020191506014902

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 Length30Millimeter

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
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
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
00191506014919AGENT™BOSTON SCIENTIFIC CORPORATIONOOB2024-03-21