07/29/2014
https://www.congress.gov...
"Now, America leads the world in the development of innovative and life-sustaining medical devices."
"I guarantee that."
"A supplemental PMA, which is required for any change of any kind, is required to be approved by FDA, using the same standards of safety and effectiveness as the original PMA."
"I've had extensive experience with the FDA, and they don't miss much."