21 CFR 882.5030 — Methyl Methacrylate For Aneurysmorrhaphy
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5030
Identification
Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JXH | Methyl Methacrylate For Aneurysmorrhaphy | 2 | 3 | Implant |