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FDA Statement FOR IMMEDIATE
RELEASE Statement July 28, 2005
FDA Statement on
Approvable Letter to Mentor Corporation
The U.S. Food and Drug
Administration (FDA) today issued an approvable letter to Mentor Corporation
for their application for silicone gel-filled breast implants. Federal law
and regulations prohibit the government from discussing the specific
contents of the letter.
However, an approvable
letter is one of several intermediate steps in the FDA review process of new
products. Previously at their April 2005 meeting, the General and Plastic
Surgery Devices Advisory Committee voted 7-2 that Mentor’s application was
“approvable with conditions.” This letter does not mean that the device is
approved for marketing in the United States at this time.
Up to the
Minute: News Articles about Silicone Gel
Implants
Recovering, finally,
from the breast implant panic
-
Chicago Tribune - November 30, 2006
Silicone implants'
return could keep doctors busy
- USA
Today - 11/19/2006
Ban on Silicone Breast
Implants Lifted - AP - 11/17/06
FDA Lifts 14-Year
Moratorium on Implants - ABC News - 11/17/06
Silicone gel breast
implants approved for return to Canadian market - CP 10/21/06
Allergan, Mentor May Sell Silicone Implants in
Canada - Bloomberg 10/20/06
Investigation Nixes
Silicone Breast Implant Allegations -
AP- 7/28/06
Inamed
Silicone Implants Get Conditional Approval
from FDA-
AP- 9/21/05
Inamed Breast Implants
Get Conditional FDA OK
- Reuters -
9/21/05
Inamed
Silicone Implants Get Conditional Approval
from FDA-
AP- 9/21/05
Where's the Choice? -
Sally Satel - The National Review - 8/22/05
Last Implant Gasp? -
The Washington Times - 8/21/05
Controversial silicone
implants may return - UPI - 8/16/05
FDA: Silicone-gel breast implants on way back
- 7/30/05
FDA Move on Breast Implants Draws Swift Reactions
- 7/30/05
Breast-Implant Maker Gets 'Approvable Letter' From FDA
- 7/29/05
Plastic Surgery
Societies Applaud FDA 'Approvable with Conditions' Letter - 7/28/2005 6:09:00 PM
Mentor Gets Conditional Approval for is Silicone Gel Breast Implants -
Street.com 7/28/05
FDA Statement on Approvable Letter to Mentor Corp. re: Silicone Gel Breast
Implants - 7/28/05
Mentor's Silicone Gel Breast Implants Get FDA OK - Reuters 7/28/05
Mentor Approvable
Letter From FDA for Silicone Gel-Filled Breast Implants - 7/28/05
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Breast Implants