Indications for Use - Is it possible to have a different indication for use

S

Sphinx

#1
Is it possible to have a different indication for use for the same device in the EU and the US?
 
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Highground

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#3
Can you have two different indication for use in the same IFU if you separate the sections per country?

This is based on a device that has CE in the EU for a special fluid and a device that will be submitted to FDA soon, but with the addition of the special fluid and water. Will these identical devices need different production codes as well.
 
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