07/23/2013
https://www.congress.gov...
"I'm really glad you did what you did, and I'm glad you've had that result."
"I've had extensive experience with the FDA, and they don't miss much."
"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."