Overview of Project A medical device company with an approved wound healing product on the market wanted to expand the labeling for its device without going through the full FDA pre-market approval (PMA) process. Project Details ISIS worked with the principal investigator to set up and conduct a 25-animal chronic study, allowing the company to obtain a 510(k) approval based on the animal data alone. Outcome of Project In this way, ISIS enabled its client to increase the market for its device without having to perform costly and time-consuming clinical trials.