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Intrasaccular Flow Disruption Device

Page Type
Product Code
Definition
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
Physical State
A metal mesh-like implant attached to a delivery system.
Technical Method
An intrasaccular flow disruption device is a prescription use only device used to treat wide-neck intracranial aneurysms. The device is delivered into the neurovasculature with an endovascular approach, implanted within the sac of the intracranial aneurysm, and covers the neck of the intracranial aneurysm to obstruct blood from entering the intracranial aneurysm sac.
Target Area
Neurovasculature, intracranial aneurysms.
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 OPR 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.

Intrasaccular Flow Disruption Device

Page Type
Product Code
Definition
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
Physical State
A metal mesh-like implant attached to a delivery system.
Technical Method
An intrasaccular flow disruption device is a prescription use only device used to treat wide-neck intracranial aneurysms. The device is delivered into the neurovasculature with an endovascular approach, implanted within the sac of the intracranial aneurysm, and covers the neck of the intracranial aneurysm to obstruct blood from entering the intracranial aneurysm sac.
Target Area
Neurovasculature, intracranial aneurysms.
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 OPR 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.