This type of stroke is the most common. A blood clot â a clump of blood that sticks together â is usually to blame for ischemic strokes. They can also happen when arteries become narrow and clogged with plaque. Plaque is a mix of cholesterol and other fatty stuff that sticks to the walls of blood vessels.
Premarket Approval (PMA) A PMA submission is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Human use data from a formal clinical study is almost always required in addition to laboratory studies.
Questions & Answers on Bisphenol A (BPA) Use in Food Contact Applications. FDA acknowledges the interest that many consumers have in the safe use of Bisphenol A (BPA) in food packaging. FDA has performed extensive research and reviewed hundreds of studies about BPAâs safety. We reassure consumers that current approved uses of BPA in food containers and packaging are safe. Additional research is underway to enhance our understanding of BPA. FDA will take these studies into account as it continues to ensure the safe use of BPA in food packaging.