ISPINE.ORG Forum - Pro-Disc-C receives FDA approval letter

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mmglobal

10-26-2007 03:22 AM

Pro-Disc-C receives FDA "approvable" letter

See the GPN NASS blog for more info on todays sessions. The big news today was when Dr. Dan Murrey announced that Synthes had received the anticipated approval letter from the FDA indicating that the review of the clinical data was complete. The approval process is now pending review of manufacturing process, packaging, etc..

Big news for cervical patients!

Mark

sahuaro

10-26-2007 05:05 AM

This is big, indeed. Do you have a guess on how long the final stages will take?

mmglobal

10-26-2007 11:54 AM

ProDisc-L got their letter in January 2006. Actual approval came more than 8 months later, in August.

mmglobal

10-26-2007 11:54 AM

ProDisc-L got their letter January 5, 2006. Actual approval came more than 8 months later on August 18th.

Maria

10-27-2007 04:09 PM

Just one word

AwesomeAwesomeAwesome

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