UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
of the
SECURITIES EXCHANGE ACT OF 1934
Date of Event Requiring Report: December 15, 2000
NOVAMED, INC.
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(Exact Name of Registrant as Specified on its Charter)
O-26927 77-0443643
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(Commission File Number) (IRS Employer
Identification Number)
NEVADA
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(State or Other Jurisdiction of Incorporation or Organization)
623 Hoover Street, N.E.
Minneapolis, Minnesota 55413
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(Address of Principal Executive Offices)
(612) 378 1437
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(Registrant's Telephone Number, Including Area Code)
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ITEM 5. OTHER EVENTS
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On December 11, 2000, the Medical Device Agency ("MDA") of the UK Department of
Health issued a Device Alert in connection with a recall of the Company's
NovaGold(TM) breast implant product. The decision to issue a Device Alert was
made after discussions with the Company's subsidiary Novamedical GmbH, which
voluntarily agreed to suspend any further shipment or sale of the NovaGold(TM)
product in the United Kingdom until such time as the MDA is satisfied that the
Company has completed an "adequate" biological safety assessment of the
Company's hydrogel filling material. The Device Alert does not advise that the
NovaGold(TM) breast implant is unsafe, rather the MDA's position is that the
Company has not met the European device regulations for selling breast implants.
The Device Alert states that the MDA has not identified any definite risk
associated with the NovaGold(TM) implant and does not recommend explantation for
the approximately 250 patients identified in the United Kingdom. The Alert also
states that there is no information to indicate that there are specific risks to
women or their children, either during pregnancy or from breast feeding,
associated with the NovaGold(TM) breast implant.
The Company has engaged technical, regulatory and scientific specialists to
reexamine all design evidence for the product, including test data. The results
of this reexamination will determine what further action on the part of the
Company, including new testing, is required to satisfy the MDA's mandate.
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.
Dated: December 15, 2000
NovaMed, Inc.
By:/s/ Ruairidh Campbell
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Ruairidh Campbell, President