Just to provide information for those in the dark! Our PMA submission scheduled to be submitted was postponed due a third party supplier contamination error. What does this mean. It means the sample to be submitted was contaminated and the resulting affect was for the "PH" factor to be high and unacceptable for submission! What does that mean? Interpreted in lab terms to high of a ph will not meet FDA requirements. " The testing results showed several anomalies in product pH level and moisture content that the company, in consultation with the laboratory leadership, believes resulted from unintended partial oxidation during the sample cutting and packaging process that was conducted by an external component supplier. The company notes that this process was carried out to create testing samples and is not an element of the standard manufacturing, packaging and sterilization process that will be reviewed by the FDA in the PMA application. UHP notes further that testing results for other characteristics, such as chloride content, were well below tolerance thresholds in all samples."
$5-$10+