Cognis..... :(







How can you break the BSX tradition of at least an advisory/recall/shipping halt every quarter?

In case BSX achieve a quarter without any advisory, President Obama will award Ray Congressional Medal of Honour!

Ray is a Canuck. Prime Minister Stephen Harper and Queen Elizabeth II will award him with a Maple Leaf and he will be knighted also. Say hello to Sir John Raymond Elliott
 






Ray is a Canuck. Prime Minister Stephen Harper and Queen Elizabeth II will award him with a Maple Leaf and he will be knighted also. Say hello to Sir John Raymond Elliott


Thanks guys, I am overwhelmed....

If HRH Queen award me the knighthood and PM Harper a Maple Leaf I will accept them on behalf of all the hardworking staff of BSX.
 
















































BTK - Exploding devices in europe
MDT - Fidelis - single largest disaster to date in crm
STJ - Riata - punching holes in the heart & relaunched as DURATA (Even the reps couldn't prevent this by simply not returning product). And the PPR is a total JOKE.

to sit high and mighty because as of today, your company of choice has a new and shiny product, is just silly.

bunch of whiny punks around these parts.
 






BTK - Exploding devices in europe
MDT - Fidelis - single largest disaster to date in crm
STJ - Riata - punching holes in the heart & relaunched as DURATA (Even the reps couldn't prevent this by simply not returning product). And the PPR is a total JOKE.

to sit high and mighty because as of today, your company of choice has a new and shiny product, is just silly.

bunch of whiny punks around these parts.

Love seeing this on this board. The list of advisories and recalls on the BSC website is over 25 pages long, BSC hasn't been more than 2 quarters without a recall or advisory, and every device in your bag going back to 2000 has some sort of recall associated with it. Oh, my bad, Contact TR doesn't. Good work.
 




































You can go to bsci international website and see what the replacements. They are currently approved in the EU and have been being implanted. As for the U.S. release date, someone else has to answer that one.
 






You can go to bsci international website and see what the replacements. They are currently approved in the EU and have been being implanted. As for the U.S. release date, someone else has to answer that one.

Why it is always that medical device manufacturers first obtain marketing approvals in EU and then (after a year or two) they obtain approval from US FDA!

It appears that as EU notified bodies get their income from their clients therefore it becomes very difficult to create any problems during the approval process. If they do next time the manufacturer will not go to them.
 






Why it is always that medical device manufacturers first obtain marketing approvals in EU and then (after a year or two) they obtain approval from US FDA!

It appears that as EU notified bodies get their income from their clients therefore it becomes very difficult to create any problems during the approval process. If they do next time the manufacturer will not go to them.

Are there any means to obtain quick FDA approvals?