I bet that depends on what's on the label. If it says the pacemaker is good to 7 atmospheres (about 200 feet) on the label then I suspect they're going to have to go through clinical trials before it's approved for sale. Don't all medical devices/medicines have to be tested on humans before they're approved?
I suspect it does not have to be tested in humans pressurized to 7 bar, though, to put "tested to 7 bar" on the label.