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.
Question: What is a Corrective Action Report? Answer: A Corrective Action Report (âCARâ) is a document that a laboratory must prepare and submit to the Departmentâs Laboratory Accreditation Program (âLAPâ), usually in response to the LAPâs âReport of an Assessmentâ.