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www.fdanews.com/articles/132623-sanuwave-submits-first-pma-module-for-diabetic-foot-ulcer-device

Sanuwave Submits First PMA Module for Diabetic Foot Ulcer Device

December 10, 2010
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.