Med-El Warning Letter

[Boult]

Thanks to Bob of bhNews;

For any curious, here's the FDA Warning Letter to Med-El, dated November 16, 2004:

http://www.fda.gov/foi/warning_letters/archive/g5089d.pdf

This was followed by an Import Block

Bob

 

[AlleyCat]

Since it was written 2004, hopefully those issues have been resolved. I'd be interested in seeing a follow-up on that. I wonder what information was "blacked out".

 

[Pinky]

It was happened in 2004. Why someone put a black pen to remove the words?? They said it coming from in Austria. I hope it's problem the solve. Must be FDA approved before surgery.

 

[SouthFella]

Also, there was no internal device failures as Advanced Bionics had. And not one MedEl rep lied to me . I won't say that about the other 2 companies here in the USofA. And one of the companies is near me in Colorado !!!

Prospective CI ers do yer research and make phone calls and ask questions, BEFORE you go under the knife. Contace me if you want.

 

[rockdrummer]

What's with the blacked out areas where we cant' read what is said.