Wow, this gets complicated. Consider this one please: How about taking a device that would be a class II, (IIb in the EU) and combining it with a class III? Of course in this situation the II is by default a III, but can the class II later be filed as only a 510(k), by itself? Or would the class II manufacturer be smarter to not jump onto the PMA, but get the PMA holder to create a device master file?