Orthopaedic and Rehabilitation Devices Panel - Sept 8/9

[David]

FDA Agenda here

If I am reading it correctly, from a Prodisc approval standpoint, about the only thing I notice is:

"The committee will also hear an update on the status of recent devices brought before the committee."

...and...

"On September 9, 2005, the committee will discuss the design of clinical studies for spinal devices indicated for treatment of mild to moderate low back pain"

I believe someone else asked this recently, but is there anyone who lives in DC/VA/MD area?

"On September 8, 2005, from 8:30 a.m. to 6 p.m., the meeting will be open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by August 29, 2005"

David

[nanfromsactown]

This link is not working. I'm getting an HTTP 500 error.

[letteski]

Can't wait to see what tomorrow will bring.......? Thanks for keeping us posted David.

[Poncho]

September 8th should yield a good day I hope because it is my b-day I hope this day brings us closer to approval.

[Harrison]

Anyone know the fallout from this event yet? Pls post if you find / hear anything.

[cervie queen]

If I only had mild to moderate back pain, I'd put up with it and not consider surgery. why aren't they concentrating on the Moderate to severe back pain?

[letteski]

Amy is right nothing posted yet but for those of you that want to check this try this link.

http://www.accessdata.fda.gov/script...ory/search.cfm

You have to choose the "Orthopaedic and Rehabilitation Devices Panel" past meetings go to the bottom and you will find all the info on the meeting. Summary and Transcripts is what we are looking for.

Lets not get our hopes up, this meeting was on how to conduct a study.

[letteski]

And this is what our hard earned tax dollers goes to, people that can�t make any determination on how to get the American�s with back pain the surgical treatment they need quicker and more efficiently. We have been waiting months for a meeting and they talk about things that have no outcome in the end.

Mind blowing to me guess it will be more time before we see if this meeting is going to make a difference for all of us in pain today. Safety at its finest.