Paradigm Medical Industries Inc. (PDMI)

[stervc]

The FDA Approval Time Frame for PDMI…

I eventually had gotten through to speak to some of the FDA officials a while from making a few phone calls. Here’s what I was told in general as I will reference it to PDMI which could be verified from the link below under the section towards the end titled 510(k) Status Program:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

FDA approval for a device usually takes less than 90 days providing everything is properly done. Since PDMI has already submitted this 510(k) application before and have been going back and forth with the FDA officials over the past 8 months or so to ensure that everything is in order, I expect that we could possibly see an approval any day now. Here's why...

Under the 510(k) Status Program, PDMI is only required to request for an update of the status of their 510(k) application 90 days after their initial log-in. Their initial log-in was months ago as many of who have been following PDMI already know. PDMI can only request status reports every 30 days following the initial status request. PDMI will obtain a status report by filling out the status request form, FDA 354114, and fax it to the CDRH office identified on the form. Then within three working days after a status request is received, CDRH will send PDMI a fax that includes the last action taken on their submission and all other pertinent information.

It is very obvious that for the company to have released this last PR informing us that they have submitted their 510(k) application for FDA approval of their Retimax/Paramax device of which many of us had already known 8 months ago, is a huge subliminal hint that they have been informed of an update from the FDA officials to confirm that their approval is near at hand. They definitely know something that is very positive and very strong. Please, this is how I am seeing things and I recommend that all do their research to confirm their own thoughts. I would hate to be wrong about this, but this is how I am seeing things from my coordination with some neutral FDA officials on the matter.

v/r
Sterling