FDA.reportPublic FDA data

AGENT™

Primary DI
00191506014841
Brand
AGENT™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7493960820400
Catalog number
H7493960820400
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
00191506014841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506014841001915060148411915060148410191506014841

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 Diameter4Millimeter
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
00802526629907CanGaroo®66BC05-10066BC05-1002026-05-27
00802526629914CanGaroo®66BC04-10066BC04-1002026-05-27
00802526629921CanGaroo®66BC02-10066BC02-1002026-05-27
00802526629938CanGaroo®66BC01-10066BC01-1002026-05-27
00802526629945CanGaroo®66BC03-10066BC03-1002026-05-27
00802526630002EluPro™66BE02-10066BE02-1002026-05-27
00802526630019EluPro™66BE03-10066BE03-1002026-05-27
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28

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
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