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I have a implantable device which was 510k cleared a couple of years ago. I just submitted and had cleared a 510k modification to that same device using the previously cleared device as my predicate. Now I want to submit an abbreviated 510k to add an additional intended use to the same devices mentioned above. My question is. Can I use my 2 already cleared device as my predicates, or should I use other cleared devices by different manufacturers with the exact intended use. Note: Other cleared device have 3 intended uses stated. my device has 2 of the same 3. I am adding the 3rd use which will be identical at that point to the other manufacturer intended use.
It may expedite the review process but then again it can take more time and work to prepare, hence the overall benefit would be questionable. You should preferably closely look at all options and make a rational decision.