SENATE AMENDMENT

    Bill No. SB 1396

    Amendment No.    

                            CHAMBER ACTION
              Senate                               House
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11  Senator Burt moved the following amendment to amendment

12  (112464):

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14         Senate Amendment 

15         On page 1, lines 21-29, delete those lines

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17  and insert:  exempt from this section and s. 499.041(6) if:

18         (a)  The manufacturer's medical devices are approved

19  for marketing by, or listed with the federal Food and Drug

20  Administration in accordance with federal law for commercial

21  distribution; or

22         (b)  The manufacturer subcontracts with a manufacturer

23  of medical devices to manufacture components of such devices.

24         (9)  However, the manufacturer must submit evidence of

25  such

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    2:30 PM   03/23/99                                s1396b-16X7w