Prodisc and the Fda

[chasswen]

a few more steps closer to germany
we close on the loan monday
must open account at bank of america for a surely worken atm card overseas
blood work on wed the 14th
ekg june 26th
and must get chest xray
airline tickets purchased
still waiting on pass ports
i would like all the results of test here before wiring money
and anita has i think found us a open apartment open durning the octfest in straubing aug 11 to the 21th
my god my nerves are doing back flips.
hopefully fda approves prodisc soon because if dr b uses prodisc on me i think im going to sue those idiots at blue crap
my best
chuck

[Dina]

Ok so no phone call on Friday either. When my nurse case manager told me that we would hear something by the end of the week, I should have asked him, "by the end of what week, December?"
This is b.s.

[chasswen]

yippee pass ports accounted for early july
now just need postive place to stay for the 3 weeks there. during voltsfest
chuck
p/s im gaining on it

[Mariaa]

I've edited this post.. I've been told quite a few times now by surgeons that Prodisc FDA approval is right around the corner.

I'm not holding my breath for approval of 2 level ADR implantation anytime soon..

I'd be happy to see the amount of cash WC is proposing in terms of settlement for future medical care would well take care of surgical needs in Europe with Dr.B and maybe a few ESIs here if needed post surgery and $ for meds and a f/u here and there~

[chasswen]

i think im done all but place to stay from aug 11th to the 18th. although if im not up to flying home yet could go hang out in munich. if anita comes up with the apartment wife and her dad will stay in town untill im out of the hospital and head off to the apt. works for me still waiting to hear from her again.all i must do is get pass this few tests blood work and chest xray and ekg and of course my nerves.
by the time i get there ill be so stressed out my blood pressure may be off the charts.
chuck

[Mariaa]

Here we are at the last week of June and no Prodisc FDA approval yet.

Just had my 3rd discogram which was concordant for pain at L4/5 and L5S1 so hypothetically speaking I'm a candidate for the surgery proposed by my treating OSS w/Charite disc at L4 and peek cage at L5S1 no rods/screws. Would be the same at The Spine Center tho with Prodisc if it were approved, and the surgeon had responded to necessary paperwork requested by WC..
Or can go to Europe if get settled out by WC with enough cash to cover surgery, trip some care when return..
Still have options and am still pleased w/this tho wish for everyone's sake that Prodisc at least one level would be FDA approved sooner than later~

[David]

Gotta love the waiting game, 'eh?

My fingers are crossed that Prodisc is approved within the next months. Since we haven't heard anything since January, I would like to think that *maybe* it will be single and multi-level approval, but I am not holding my breath.

My waiting window closes in December. If nothing Prodisc happens by December, then I will make arrangements with Dr. B, and have Dr. Y do my follow-up work state-side.

David

[Dina]

Hi Everyone,
Last week I called Dr.Kropfs office and was able to get some information regarding what was going on with the approval for Prodisc. They told me that it was approved 2 weeks ago, and the only thing they are waiting for is a hard copy of the approval letter to be sent over. Once that is sent over, they will start calling patients and scheduling surgeries. All patient charts for the Prodisc procedure are all in Santa Monica stacked up. (Whoever has doctors at Spine Institute.) So guys, it will be soon. I was also told months ago by FDA that after something is approved, it takes about 6 months after to be officially approved. January it was approved, and here we are, almost in July, so that makes it 6 months. I am sure that all of us here that are waiting will be getting our surgery very soon. Positive thoughts guys, come on, we are almost there.

[David]

<STRIKE>My understanding (and I could be wrong) is that once a medical device is approved by the FDA, there is a 3 month "waiting" window before it can start being used</STRIKE> (in retrospect this 3 month time frame might have something to do with being able to use Prodisc as the control group for the Activ-L study only)

So....the fact that we are almost 6 months later after an "approvable letter" (and not an an approval letter) makes me wonder what the heck is going on (if anything).

David

[Harrison]

If it were approved, I could not find it in the FDA database; but you have to be fairly careful/experienced to find anything in there:

http://www.accessdata.fda.gov/script.../cfPMN/pmn.cfm

As far as a 3 month window for waiting -- I'm no 510K expert, but that seems odd!