The FDA said today it granted Innovatex Class I classification for its Tear Duct Occluder nasolacrimal compression device.
The Tear Duct Occluder device is a designed to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts, according to the FDA.
The company submitted a request for reclassification to the FDA in June 2 years ago, according to an FDA release.
The federal watchdog said it reviewed the request to move the device to Class I, under which “general controls” by themselves are sufficient to assure “safety and effectiveness of the device for its intended use.”
The FDA said that while it granted the company’s de novo request, it did not determine that the device complies with other requirements and the company will have to confirm compliance.
The post Innovatex wins down-classification for tear duct occluder from FDA appeared first on MassDevice.
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