Sanuwave Health has submitted to the US Food and Drug Administration (FDA) the second module of its Premarket Approval (PMA) application for the dermaPACE device for the treatment of diabetic foot ulcers (DFU).
Through the acceptance of a shell application in August 2010, Sanuwave received FDA permission to file the PMA for dermaPACE in a series of three sections or ‘modules’.
In December 2010, the company submitted the first module, which included preclinical data and the results of prior clinical testing.
The second module contains the Quality System and Manufacturing review and the company plans to submit the third and final module of the PMA in the first quarter of 2011.
The final module will contain the PMA application, data from the pivotal Phase III, Investigational Device Exemption (IDE) clinical trial, proposed product labeling, and a summary of safety and effectiveness.
Sanuwave president and CEO Christopher Cashman said that the filing of this second PMA module brings them one step closer to their goal of securing approval of dermaPACE for the treatment of diabetic foot ulcers.