Jump to content
RemedySpot.com

Re: & Nephew merge with MMT...........................

Rate this topic


Guest guest

Recommended Posts

Guest guest

Rog:

I agree!. I pointed this out several months ago in a number of

posts. They will wait until Corin or get approval from the

FDA. Then they can apply for approval " as safe and effective as

the predicate device " . Thus they will avoid the expense and delay

of a clinical trial.

By the way, we seem to be getting closer to approval. Maybe by the

end of the summer. Next meeting for orthopedic devices is not

until June. No way to know without official announcement by the

FDA. The manufacturers are prohibited from any premature

announcement.

(MD in NC).

(L) C+, 3/31/03 Dr. Vail

> One point of interest especially for those US citizens that

appears

> important is covered by the the following part of the press release

>

> " The BHR procedure has been used in over 27,000 patients since

1997

> and has significant clinical experience, particularly in the UK,

> Germany and Australia. & Nephew intends to pursue Food and

> Drug Administration approval of the product in the United States. "

>

> Those who are going the Belgium route will have cover back home.

>

> Rog BHR both hips 2001 Mr Treacy

>

>

Link to comment
Share on other sites

Guest guest

Rog:

I agree!. I pointed this out several months ago in a number of

posts. They will wait until Corin or get approval from the

FDA. Then they can apply for approval " as safe and effective as

the predicate device " . Thus they will avoid the expense and delay

of a clinical trial.

By the way, we seem to be getting closer to approval. Maybe by the

end of the summer. Next meeting for orthopedic devices is not

until June. No way to know without official announcement by the

FDA. The manufacturers are prohibited from any premature

announcement.

(MD in NC).

(L) C+, 3/31/03 Dr. Vail

> One point of interest especially for those US citizens that

appears

> important is covered by the the following part of the press release

>

> " The BHR procedure has been used in over 27,000 patients since

1997

> and has significant clinical experience, particularly in the UK,

> Germany and Australia. & Nephew intends to pursue Food and

> Drug Administration approval of the product in the United States. "

>

> Those who are going the Belgium route will have cover back home.

>

> Rog BHR both hips 2001 Mr Treacy

>

>

Link to comment
Share on other sites

Guest guest

Rog:

I agree!. I pointed this out several months ago in a number of

posts. They will wait until Corin or get approval from the

FDA. Then they can apply for approval " as safe and effective as

the predicate device " . Thus they will avoid the expense and delay

of a clinical trial.

By the way, we seem to be getting closer to approval. Maybe by the

end of the summer. Next meeting for orthopedic devices is not

until June. No way to know without official announcement by the

FDA. The manufacturers are prohibited from any premature

announcement.

(MD in NC).

(L) C+, 3/31/03 Dr. Vail

> One point of interest especially for those US citizens that

appears

> important is covered by the the following part of the press release

>

> " The BHR procedure has been used in over 27,000 patients since

1997

> and has significant clinical experience, particularly in the UK,

> Germany and Australia. & Nephew intends to pursue Food and

> Drug Administration approval of the product in the United States. "

>

> Those who are going the Belgium route will have cover back home.

>

> Rog BHR both hips 2001 Mr Treacy

>

>

Link to comment
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...