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 CodeDevice NameClassDevicesAttributes
JXHMethyl Methacrylate For Aneurysmorrhaphy23Implant
Innolitics

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