NOVAMED INC
8-K, 2000-12-18
BLANK CHECKS
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                                  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.
            --------------------------------------------------------
             (Exact Name of Registrant as Specified on its Charter)


         O-26927                                             77-0443643
         -------                                             ----------
 (Commission File Number)                                  (IRS Employer
                                                       Identification Number)


                                     NEVADA
                            ------------------------
         (State or Other Jurisdiction of Incorporation or Organization)




                             623 Hoover Street, N.E.
                          Minneapolis, Minnesota 55413
                    ----------------------------------------
                    (Address of Principal Executive Offices)


                                 (612) 378 1437
                -------------------------------------------------
              (Registrant's Telephone Number, Including Area Code)






<PAGE>


--------------------------------------------------------------------------------

ITEM 5.  OTHER EVENTS

--------------------------------------------------------------------------------


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
                                              -------------------------------
                                              Ruairidh Campbell, President







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