-+ 0.00%
-+ 0.00%
-+ 0.00%

Monogram Technologies Receives Additional Information Request From FDA On September 30, 2024, Regarding Its 510(K) Premarket Filing Submission For mBôs TKA System

Benzinga·10/02/2024 22:04:24
Listen to the news

The Application was submitted on July 19, 2024, and passed the initial FDA Administrative Review. The FDA informed the Company that the FDA placed the Application on hold pending a complete response to the AIR.

The FDA has informed the Company that the Company has 180 days from the date of the AIR to provide a complete response to the AIR or the FDA will consider the Application withdrawn.

As the Company works to respond to the AIR, the Company, in parallel, will pursue a submission for its active modality with Outside the United States ("OUS") clinical data as it continues to work through the AIR for its semi-active system.