Home » Sanuwave Submits First PMA Module for Diabetic Foot Ulcer Device
Sanuwave Submits First PMA Module for Diabetic Foot Ulcer Device
Sanuwave Health has submitted the first module of its PMA application to the FDA for dermaPACE, a device to treat diabetic foot ulcers. The module included preclinical data and results of prior clinical testing, the company says. It expects to submit the second module, containing a quality manufacturing system review, later this month. The final module — which will include data from a recently completed Phase III clinical trial, proposed labeling, and a safety and effectiveness summary — will be submitted in the first quarter of 2011.
Upcoming Events
-
25Apr
-
07May
-
14May
-
30May