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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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): March 27, 2000
INAMED CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware 59-0929629
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(State of Incorporation or Organization) (IRS Employer Identification No.)
001-09741
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(Commission File Number)
5540 Ekwill Street - Suite D, Santa Barbara, California 93111-2919
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(Address of principal executive offices) (Zip Code)
Not Applicable
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(Former Name or Former Address, if Changed Since Last Report)
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Item 5. Other Events.
The Registrant announced that the Food and Drug Administration has
completed an initial review, and has accepted for filing, the pre-market
approval (PMA) application for the Lap-Band(R) Adjustable Gastric Banding
Systems, an obesity treatment device which is manufactured by Inamed's
BioEnterics Corp. subsidiary. The Press Release announcing the status of the
Registrant's Lap-Band(R) System PMA filing is attached hereto as Exhibit 99.1.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(a) Not applicable
(b) Not applicable
(c) Exhibits:
The following exhibits are filed herewith:
Exhibit Description
99.1 Press Release, dated March 27, 2000.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Company has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
INAMED CORPORATION
BY:
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Name: David E. Bamberger
Title: Senior Vice President,
Secretary and General Counsel
Date: March 27, 2000
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EXHIBIT INDEX
99.1 Press Release, dated March 27, 2000.
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Exhibit 99.1
Inamed Corp. Announces Status of Lap-Band System PMA Filing.
SANTA BARBARA, Calif.- (BUSINESS WIRE) - March 27, 2000 - Inamed Corp. (Nasdaq:
IMDC-news) today announced that the Food and Drug Administration has completed
an initial review, and has accepted for filing, the pre-market approval (PMA)
application for the Lap-Band(R) Adjustable Gastric Banding System, an obesity
treatment device which is manufactured by Inamed's BioEnterics Corp. subsidiary.
This filing was made on February 9, 2000, following several years of extensive
clinical testing in the United States and abroad. The Lap-Band(R) System is
currently being sold commercially in various international markets, including
Europe, Australia and Mexico, with more than 40,000 patients receiving this
implant device since 1993.
The Lap-Band(R) System is designed to enable extremely obese people to achieve -
and maintain - significant weight loss, and thereby dramatically improve their
quality of life.
Inamed has also been advised by the FDA that an advisory panel will be convened
to hold a public hearing in June 2000, at which time the PMA filing will be
formally reviewed and considered by the panel.
Inamed is a global surgical and medical device company engaged in the
development manufacturing and marketing of products for the plastic and
reconstructive surgery, aesthetic medicine and obesity markets.
Inamed sells a variety of lifestyle products used to make people look younger
and more attractive including breast implants for cosmetic augmentation and
collagen-based facial implants to correct facial wrinkles and to improve lip
definition.
Inamed also sells products that address women's health issues, including breast
implants for reconstructive surgery following radical mastectomies, and devices
that treat severe obesity and urinary incontinence.
Contact:
Inamed Corp.
Ilan Reich/Michael Dory, 212/273-3430
