to find no preemption in the premarket approval
In 1988, only 46 of the more than 5,000 devices approved for marketing by the FDA went through the premarket approval
The submission of a premarket approval
(PMA) application is a major step forward in expanding the availability and accessibility of allograft heart valves to cardiovascular surgeons," noted Steven G.
EPITOPE'S ORASURE PREMARKET APPROVAL
APPLICATION SCHEDULED FOR REVIEW
BAXTER SUBMITS PREMARKET APPROVAL
APPLICATION FOR HEART ASSIST SYSTEM
EPITOPE RECEIVES FDA RESPONSE TO PREMARKET APPROVAL
This will be the third Premarket Approval
Application (PMA) voted for panel approval since 2002 for INFUSE Bone Graft.
Approval of the premarket approval
application is for the WaveLight ALLEGRETTO WAVE([R]) Eye-Q Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of myopic refractive errors up to -12.