RE: [bhNEWS] Cochlear says implant recall to cost up to A$150 mln

[Guest guest]

My comments on certain statements in the article - see asterisks in excerpt:

" Even after the cause is determined, Cochlear will need to run clinical

tests

and win regulator approval to return to market. "

*Assuming only a gremlin in the manufacturing process, clinical trials would

not be indicated.

" The U.S. Food and Drug Administration can take up to 180 days to review

data. "

*While true, most likely a 30 day Notice (extended to a 135 day track in

certain cases) for PMA Supplement approval would be indicated in this case.

That is exactly the path taken in Advanced Bionics' recent recall, which

involved a change in the manufacturing process.

FWIW...

Bob

...................

From: bhNEWS [mailto:bhNEWS ] On Behalf Of

MacPherson

Sent: Monday, October 17, 2011 8:05 PM

bhNEWS

Subject: RE: [bhNEWS] Cochlear says implant recall to cost up to A$150 mln

 

Reuters - October 17, 2011 (Update)

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Cost of Nucleus 5 recall seen at A$130 mln to A$150 mln

SNIP..........