Last synced on 27 January 2023 at 11:04 pm

Intracranial Coil-Assist Stent

Page Type
Product Code
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.
Physical State
The device is a tubular mesh permanent implant that is attached to a delivery wire.
Technical Method
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.
Target Area
Neurovasculature
Review Panel
Neurology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QCA 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.

Intracranial Coil-Assist Stent

Page Type
Product Code
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.
Physical State
The device is a tubular mesh permanent implant that is attached to a delivery wire.
Technical Method
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.
Target Area
Neurovasculature
Review Panel
Neurology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QCA 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.