Last synced on 23 September 2022 at 11:05 pm

Polymerizing, Neurovascular Embolization Material

Page Type
Product Code
Definition
The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.
Physical State
the embolization agent is dissolved in DMSO (dimethyl sulfoxide, an organic solvent); ethylene vinyl alcohol co-polymer (EVOH, the embolization agent) upon contact with aqueous solutions such as blood or saline, precipitates in situ forming a spongy/solid embolus - the micro-catheter is threaded up through the femoral artery into the brain and to the site of the aneurysm. The embolic solution (EVOH plus DMSO) is slowly infused, and thereby the material precipitates.
Technical Method
intravascular embolization
Target Area
intracranial aneurysms as specified by indication statement
Review Panel
Neurology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code OBA 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.

Polymerizing, Neurovascular Embolization Material

Page Type
Product Code
Definition
The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.
Physical State
the embolization agent is dissolved in DMSO (dimethyl sulfoxide, an organic solvent); ethylene vinyl alcohol co-polymer (EVOH, the embolization agent) upon contact with aqueous solutions such as blood or saline, precipitates in situ forming a spongy/solid embolus - the micro-catheter is threaded up through the femoral artery into the brain and to the site of the aneurysm. The embolic solution (EVOH plus DMSO) is slowly infused, and thereby the material precipitates.
Technical Method
intravascular embolization
Target Area
intracranial aneurysms as specified by indication statement
Review Panel
Neurology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code OBA 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.