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RE: [IP] Re: Paradigm - waterproof
I received the following message from Mark Estes, whom as most of you know,
is with Medtronic. Perhaps this will satisfy your curiosity, Beverly,
regarding water and the Paradigm.
Here it is. . .
Wanted to clarify a few things for you.
The FDA did not test anything. They give us a clearance to market a pump
with a set of claims. FDA's big focus is with safety and effectiveness.
They look at the labeling, claims, test plans, test results and clinical
trial data presented by the manufacturer and make their decision based on
the information provided. In support of getting approval, we do our own
testing ( just like any other medical device manufacturer). Our tests
follow the standards set by ISO. Our first tests were for 8 feet and 30
minutes. (ISO lets the manufacturer determine some things like duration and
depth) . Why didn't we test for 24 hours the first time? We had many
other things to test on the pump so we spent our time before the launch on
other areas and we didn't feel that it would be worth delaying the launch.
After we launched the product, we found time to go back and revisit the
testing. We cannot claim what we cannot prove. Thus, we ran new tests with
longer durations. We ran tests for over 24 hours and showed that it was
still water tight. Thus, the change in the labeling and claim. Same pump,
new testing, new claim. That is how it works.
Given that the pump does not float and costs over $5000, we urge people to
be careful in and near water. Loosing your pump while surfing, shooting the
rapids, or cliff diving would not be good for anyone (us, user, insurance).
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