Fluid exchange between capillaries and the interstitial fluid. takes place between the blood and interstitial fluid across the thin endothelial walls of the capillaries. blood pressure drives fluid out of the capillaries, blood proteins pull fluid back in the capillaries by osmotic pressure. Difference in osmotic pressure and blood pressure drives fluids out of capillaries at the arteriole end and into capillaries at the venule end.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.remarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
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.