Axonics files PMA supplement for further MRI labeling

2019 02 13 19 24 5396 Fda Logo V2 400

Axonics Modulation Technologies has filed a premarket approval (PMA) supplement with the U.S. Food and Drug Administration (FDA) to secure clearance for detachable extremity coil MRI conditional labeling for its implantable sacral neuromodulation device on 1.5-tesla and 3-tesla scanners.

The company has already received FDA clearance for 1.5-tesla and 3-tesla MRI scanner conditional labeling for head and full-body transmit coils for the implantable components of its Axonics r-SNM system. The PMA supplement will allow users of the system to conduct MRI scans with detachable extremity transmit/receive coils, which will translate into better scanning setup flexibility and broader MRI access for patients, the company said.

The standard timeframe for FDA consideration of supplemental PMAs is 180 days, according to Axonics.

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