WITHOUT TIP Stent System

WITHOUT TIP Stent System
Neuroform Atlas - M003SZAS45240

A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

• Length: 24.0 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NJE

Device Name: Intracranial Neurovascular Stent

Device Class: f

Physical State: N/A

Definition: An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.

Submission Type ID: 6

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: QCA

Device Name: Intracranial Coil-Assist Stent

Device Class: 3

Physical State: The device is a tubular mesh permanent implant that is attached to a delivery wire.

Definition: An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device provides mechanical support for embolic coils that are placed into the aneurysm for treatment. The device prevents coils from prolapsing into the vessel lumen. The device is implanted using minimally invasive endovascular techniques.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Neurovasculature

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 07613252656234

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