Post by
Scruggstyle on Jul 01, 2016 1:28am
From the FDA website:
PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize use of its data by another.
Comment by
CNInvesting on Jul 01, 2016 1:43am
Great boost in confidence in the company, straight from the FDA's office. Just wait for the shorts to distort this too.