prodisc

i was told today from the guy at work who knows someone in the fda,that prodisc PASSED 510K mfg inspection last week for tier 1 level FDA approval.
should be offical in the next few weeks.
YIPPEEE
chuck

[David]

Hopefully that is true, as that is excellent news.

The sooner 1 level Prodisc is approved for U.S. usage, the sooner 2 level Prodisc is approved for U.S. usage (and ultimately, the sooner Dr. Y schedules me for surgery)

David

[Kim]

This is great news! I hope that things move along quickly now lol as quickly as the govt in this darn country can move that is and to us who suffer back pain it will never be quickly enough!
Kim

[dmh]

When I was in Dr. Yue's office last Friday I over heard him say just about the same thing. They were doing a manufacturing inspection this week or next and expected the approval in the next month. Mind you this was hearsay, but I think I heard this correctly.

[Harrison]

Here's the "business side" of the story from a Swiss news source. It validates the possibility of approval in the "first half" of 2006.
_____________________________________________

28. March 2006, Swissinfo

Synthes comes of age after severing patent ties

Medical devices firm Synthes is well positioned to pursue its strategy of global expansion after buying its patents from an independent research foundation.

Full Article Here.

i told ya so {grin}
chuck

[David]

I feel the need to bump this article, in case anyone has any more recent news/info/gossip on the subject.....

Thanks.

David

me sits tapping his foot saying to himself WT!! is taking these bozo fda from getting prodisc paper work done for final approval.
ack
chuck

you already know I agree. The longer this 1 level approval takes, the more doom and gloom my chances are to get the 2 level approved before my state extended cobra ins runs out! TIME is literally running out for me!

[David]

agreed 100%.

As I like to say, the FDA runs at two speeds: slow, and stop

David