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.
For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for.