DCB ADM04025008P 04.00 L250 UL0800 US

DCB ADM04025008P 04.00 L250 UL0800 US
IN.PACT™ Admiral™ - ADM04025008P

A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.

• Length: 250.0 Millimeter
• Outer Diameter: 4.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: ONU

Device Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Device Class: 3

Physical State: The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire. The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different lesion sizes.

Definition: A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The balloon catheter uses mechanical force across a lesion to establish patency. The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00643169975033

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A