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Agent™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
AGENT™ FDA UDI
Generic Name
Coronary angioplasty balloon catheter, drug-coated FDA UDI
Device Name
Paclitaxel-Coated Balloon Catheter FDA UDI
Model / Reference
H7493960820300 FDA UDI
Description
Paclitaxel-Coated Balloon Catheter FDA UDI

Identifiers

Catalog Number
H7493960820300 FDA UDI
Primary DI / UDI-DI
00191506014827 FDA UDI
PMA Number
P230035 FDA UDI
FDA Product Code
OOB FDA UDI
GMDN Term
Coronary angioplasty balloon catheter, drug-coated FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Balloon Length — 20 Millimeter FDA UDI
Balloon Diameter — 3 Millimeter FDA UDI

Category: Coronary angioplasty balloon catheter, drug-coated

Agent™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary angioplasty balloon catheter, drug-coated.

Cleared under the same submission

P230035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI bb29e41f-3203-4811-8305-5297552fde57 36 fields · synced May 31, 2026