Tom Harkin actually said...

You're saying that a device manufacturer, like this Medtronic defibrillator, when it went through the whole premarket approval and everything, and it was approved, later on they made a change to it, but it didn't have to go back and be approved, and they did no human trials?

Context

Harkin questions the approval process for device modifications without human trials.

08/03/2009

https://www.congress.gov...

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