06/10/2009
https://www.congress.gov...
"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 guarantee that."
"Now, America leads the world in the development of innovative and life-sustaining medical devices."
"I hope I'm wrong on this count because, quite frankly, I don't believe this legislation will contribute at all to our efforts to make health care more affordable."