Anyone recall how many of the patients in clinical trial was 16-20 year olds and how many in the followup visit group were also 16-20? By eliminating these patients from trial results,how does this now effect the results? FDA wants to see a large data pool of patients for FDA approval so its important that the number of 16-20 yr olds was just a small portion of this clinical trial and small portion who made followup visits..
I am not 100% sure on the ages, but the FDA commented on their satisfaction with the overall trial data with the first submission...they basically just had some follow up questions. There were apparently no requests for additional trial data. I believe they would have asked for it at that time if they deemed it necessary for their decision.
No, it's not better than FDA approval. However, it's good news for sure. It will be nice to actually see some revenue and not just these press releases and conference calls mentioning devices being sold.
The PMA decision will be based on the submitted design...the replacement parts are irrelevant to that decision. If the replacement parts require further FDA approval, there will be a 30 day notice filed to take care of that. The initial 180 day notice is the biggie...having to file a subsequent 30 day notice will be inconsequential.