The PMA process requires substantively more input from a company. Which equals more money to submit. They may have to conduct more tests to generate the required data. Such testing can be very very expensive. Drug trials cost millions. Also the review period is 6 not 3 months. So it takes longer to hear back. Also, the PMA can flat out be denied as it is high risk new devices that get pushed into this review. The only good news is that the seeds should get through the 510(k) process. I bet that is the next submission because there probably isn't much money in the paste. If the seeds get through hopefully they can generate enough income to be profitable and pay for/wait out the PMA process. So the next step is looking for the next 510(k) submission and then waiting 3 months. The PMA will probably take three months to put together as it looks like are considering challenging the need for it. It may not be submitted for 3 or 6 months and then the 6 month wait.
Still digging and not finding good things. The current company that sells non-absorbing Y-90 beads did not get a 510(k), in fact they did not get a PMA. They ahve a HDE..."TheraSphere® is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established. "
That means that the device most like what ADMD wants to market has not yet been formally approved, so I wonder what devices they compared their product to. Anyway, hopefully the company is considering an HDE . Other than that they need to seek approval in Europe where the review process is far less costly and time consuming.
Yes Kayak, looks like we're in for a longer ride than first anticipated. I don't know how they expected an implanted nuclear device, . . . okay, maybe that's a slight exaggeration, but anyhow, the expectation to pass as a Class II device was ludicrous. Now we do need more time and more money. Now it looks like either outside support or dilution may be AMIC's next option. Hopefully the fact that the FDA did not deny AMIC will inspire some to support us via share purchase, grants or partnership. MDLAND~
Good grief, after reading more on typical class II versus III devices where in the heck did they ever get the idea radio gel would be class II??? In fact, I don't see how the seeds will be class II!!! From FDA presentation typical class II devices = ventilator, ECG, suture, syringes, powered wheel chairs, CT machines
Typical class III devices = implantable pacemakers, IUDs, extended wear soft contacts
Class II doesn't seem to include implantable objects. I believe the company was dumb, or was misinforming investors as to the probability of 510(k) approval of their products.