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.
The FDA is not bound by the panelâs recommendation, but will take it into consideration, among other things, when reviewing the Companyâs Premarket Approval application (PMA). The Company expects a final decision on approval of the PMA later this year. If approved, Cartiva SCI will be the first synthetic cartilage device ever approved by the FDA and the first PMA for any product in the forefoot.