-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, A8Y/364UXPemCv5/tpyw5pZLek34ayBgmxckmnpRQwhWDUdNOwpUjA4mcIHcEKmF ENjonjLRzCqhvYYkX+LwHQ== 0000064892-05-000044.txt : 20050802 0000064892-05-000044.hdr.sgml : 20050802 20050802151309 ACCESSION NUMBER: 0000064892-05-000044 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050802 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050802 DATE AS OF CHANGE: 20050802 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MENTOR CORP /MN/ CENTRAL INDEX KEY: 0000064892 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 410950791 STATE OF INCORPORATION: MN FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31744 FILM NUMBER: 05991689 BUSINESS ADDRESS: STREET 1: 201 MENTOR DR CITY: SANTA BARBARA STATE: CA ZIP: 93111 BUSINESS PHONE: 8058796000 MAIL ADDRESS: STREET 1: 201 MENTOR DR CITY: SANTA BARBARA STATE: CA ZIP: 93111 8-K 1 k8aug0205approvable.htm 8-K Mentor Corporation

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549


FORM 8‑K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)
July 28, 2005


MENTOR CORPORATION
(Exact name of registrant as specified in its charter)

Minnesota

 

0-7955

 

41-0950791

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)


201 Mentor Drive
Santa Barbara, California  93111
(Address of principal executive offices, including zip code)

(805) 879-6000
(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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Item 8.01       Other Events

On July 28, 2005 Mentor Corporation issued a press release announcing the receipt of a notification from the Food and Drug Administration that the Company's pre-market approval application for its silicone gel-filled breast implants is approvable, with conditions.  The press release is attached as Exhibit 99.1.

Item 9.01       Financial Statements and Exhibits 

(a)     Financial statements of business acquired

         None

(b)     Pro forma financial information

         None

(c)     Exhibits

99.1 

Press Release of Mentor Corporation announcing the receipt of approvable notification from the FDA for its silicone gel-filled breast implants.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Mentor Corporation

Date:  August 2, 2005

By:

 /s/ Joshua H. Levine

Joshua H. Levine

Chief Executive Officer

Date:  August 2, 2005

By:

 /s/ Loren L. McFarland

Loren L. McFarland

Chief Financial Officer

 

 

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EX-99.1 CHARTER 2 k8aug0205approvablepr.htm PRESS RELEASE Mentor Corporation

 

MENTOR RECEIVES APPROVABLE NOTIFICATION FROM FDA FOR ITS
SILICONE GEL-FILLED BREAST IMPLANTS

Santa Barbara, Calif. - July 28, 2005 - Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it has received an "approvable letter" from the U.S. Food and Drug Administration (FDA) for the Company's MemoryGel™ silicone gel-filled breast implants.  The approvable letter stipulates a number of conditions which Mentor must satisfy in order to receive FDA approval to market and sell silicone gel-filled breast implants in the United States. 

"We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available," said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation.  "We thank the FDA and its Advisory Panel for the rigorous and objective review of our data and related science."

"For more than a decade, choices for women seeking breast augmentation and reconstruction have been limited," said Mr. Levine.  "If ultimately approved by the FDA, Mentor's Memory Gel™ breast implants will be a significant additional option for these women.  Mentor is committed to making these important products available to women and will continue working with the FDA to address the approvable conditions."

Previously, on April 13, 2005, the FDA's General Plastic Surgery Devices Advisory Panel recommended Mentor's MemoryGel™ breast implants for approval with conditions by a vote of 7 to 2.  The vote of the Advisory Panel was based primarily upon its review of Mentor's pre-market approval (PMA) application filed in December 2003 and on the Company's PMA amendment filed in August 2004.

The conditions outlined in the approvable letter are generally consistent with the Advisory Panel's deliberations.  As is typical of FDA approvable processes, Mentor intends to engage in confidential discussions with the FDA to address these conditions, prior to the FDA's final decision on approval.

About Mentor Corporation
Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market.  The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world.  The Company's website is www.mentorcorp.com.

Safe Harbor Statement
All statements included or incorporated by reference in this release, other than statements or characterizations of historical fact, are forward-looking statements.  These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us.  Forward-looking statements can often be identified by words or phrases such as "anticipates,"  "scheduled," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "encouraged," "positive sign," "is confident," "may," "will," "should," "would," "would likely," "could," "potential," "in the future," "continue," similar expressions, and variations or negatives of these words.  In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.  These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time.  Such information is subject to change, and we will not necessarily inform you of such changes.  These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict.  Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors.

 

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The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Reports on Form 10-K, subsequent quarterly reports on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition.  Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason.

Contact:

Mentor Corporation

Investors

Media 

Peter R. Nicholson

Laura Martin

Vice President, Corporate Development

Burson-Marsteller

(805) 879-6082

(202) 530-4534

 

 

 

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