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SANUWAVE Health seeks US premarket approval for diabetic foot ulcers treatment
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SANUWAVE
: 10 January, 2011 (New Product) |
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SANUWAVE Health is submitting 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). |
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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. This second module contains the Quality System and Manufacturing review. The Company plans to submit the third and final module of the PMA in the first quarter of 2011. This final module will contain the PMA application, data from the Company’s recently completed pivotal Phase III, Investigational Device Exemption (IDE) clinical trial, proposed product labeling, and a summary of safety and effectiveness.
Christopher Cashman, President and Chief Executive Officer of SANUWAVE, said: “SANUWAVE has considerable experience with the PMA submission process as we have successfully used this regulatory pathway twice for our Class III Ossatron device. In addition, we have specific expertise with manufacturing protocols as evidenced by our ISO13485 certification. These diligent efforts underscore our capabilities and our commitment to stringent, company-wide quality systems. The filing of this second PMA module brings us one step closer to our goal of securing approval of dermaPACE for the treatment of diabetic foot ulcers.” |
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