Last synced on 30 September 2022 at 11:05 pm

Surgical Kit

Page Type
Product Code
Definition
For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Physical State
Arteriotomy SystemHUD and extension tubing for connection to a vacuum source. It is comprised of the catheter and the rings. The Elana Surgical KitHUD should only be used with the US legally marketed Spectranetics XeCl (Xenon-Chloride) Excimer Laser System, Model CVX-300.
Technical Method
The surgeon attaches the ring with the donor graft to the artery wall using a fine suture. Apply suction. For about 2 minutes the catheter tip should be held in steady contact with the artery wall. After the two minutes, the Excimer laser is activated). A train of pulses is delivered. When 200 pulses are delivered, the laser will stop automatically. The surgeon slowly removes the catheter and checks for a retrograde blood flow through the donor graft before occluding it.
Target Area
Neurovascular arteries
Review Panel
Neurology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PAX to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Surgical Kit

Page Type
Product Code
Definition
For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Physical State
Arteriotomy SystemHUD and extension tubing for connection to a vacuum source. It is comprised of the catheter and the rings. The Elana Surgical KitHUD should only be used with the US legally marketed Spectranetics XeCl (Xenon-Chloride) Excimer Laser System, Model CVX-300.
Technical Method
The surgeon attaches the ring with the donor graft to the artery wall using a fine suture. Apply suction. For about 2 minutes the catheter tip should be held in steady contact with the artery wall. After the two minutes, the Excimer laser is activated). A train of pulses is delivered. When 200 pulses are delivered, the laser will stop automatically. The surgeon slowly removes the catheter and checks for a retrograde blood flow through the donor graft before occluding it.
Target Area
Neurovascular arteries
Review Panel
Neurology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PAX to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.