Medical devices; cardiovascular devices; classification of implantable intra-aneurysm pressure measurement system. Final rule.
The Food and Drug Administration (FDA) is classifying the implantable intra-aneurysm pressure measurement system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.
D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D002532:Intracranial Aneurysm; D007427:Intracranial Pressure; D008365:Manometry / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration