Axonics files PMA supplement for further MRI labeling

By AuntMinnie.com staff writers

October 29, 2020 -- 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.


Copyright © 2020 AuntMinnie.com
 

To read this and get access to all of the exclusive content on AuntMinnie.com create a free account or sign-in now.

Member Sign In:
MemberID or Email Address:  
Do you have a AuntMinnie.com password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?
Sign in using your social networking account:
Sign in using your social networking
account: