I would suggest you read or reread the 10k. But wait let me help you.
Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices which require a pre-market approval include replacement heart valves(implanted), silicone gel-filled breast implants(implanted), and implanted cerebella stimulators.
I ask again what part of Dominion do you think will be implanted!!!