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The Big File All issues not easily categorized in the above forums are here. Comments on general health, diet, "getting comfortable," and more are here. |
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#1
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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 |
#2
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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
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47 years old Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.) L4-S1: Prodisc |
#3
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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
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Kim Herniated disc L5/S1 2000 Discectomy 10/2003 Rhizotomy 8/2004 and 3/2005Discogram 11/04 grade 7 tear L5/S1 L4/L5 Grade 5 tear with herniation and stenosis Evaluated by Dr Blumenthal at TBI 2/2005 ADR 2 level recommended 2 level lumbar fusion |
#4
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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.
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#5
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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.
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"Harrison" - info (at) adrsupport.org Fell on my ***winter 2003, Canceled fusion April 6 2004 Reborn June 25th, 2004, L5-S1 ADR Charite in Boston Founder & moderator of ADRSupport - 2004 Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006 Creator & producer, Why Am I Still Sick? - 2012 Donate www.arthropatient.org/about/donate |
#6
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i told ya so {grin}
chuck |
#7
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I feel the need to bump this article, in case anyone has any more recent news/info/gossip on the subject.....
Thanks. David
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47 years old Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.) L4-S1: Prodisc |
#8
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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 |
#9
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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!
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#10
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agreed 100%.
As I like to say, the FDA runs at two speeds: slow, and stop David
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47 years old Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.) L4-S1: Prodisc |
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