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.
A search today Monday 25March 2013 on FDA web site for 510(k) clearance or PMA approved for VANQUISH indicates there is no registration, clearance, nor approval for this device. Your articles should be more clear on the FDA status of these devices so the public is not mislead. The ALLURE article is very misleading. Other manufacturers and distributors are in trouble with the FDA for promoting, selling, and distributing a device without FDA clearance nor approval.