Companies do submit add on (abbreviated )510K all the time ...just to add very trivial control on medical device or slight change in drug manufacturing process ....
CXM PR should have clarified it ...this re-submission is not for current 510k submission ....It will be required to file add on 510k for modified process ....They must have current 510k approved ..in order to submit add on 510k
As far as I know CXM haven't received any AI letter (Addition information) from FDA ....as they are required to file 8K for AI letter ..It is a material information ...
This update in the PR could have easily been triggered by a notification from Devro that they were making changes/improvements to their manufacturing processes which would require Cardium to inform FDA accordingly.
Per the PR: "Certain changes to the manufacturing process for the collagen matrix being prepared at Devro will require modified regulatory submissions under the FDA 510(k) process"
Notice the emphasis on changes at Devro and no mention of FDA feedback. In addition, take note of "will require" meaning the changes at Devro have not occurred and when they do, Excellagen cleared or not, a modification will need to be filed. My point is that there is no mention of any CURRENT manufacturing issues or any changes made at behest of the FDA.
This modification is required of Cleared and non Cleared devices anytime a change is implemented in manufactoring.