Brief: FDA Doesn't Grant Permit For Infoscan's Med Recorder

Grupa Modne Zakupy SA

15/04/2019 07:52

April 15 (Reuters) - INFOSCAN SA  ISTP.WA :
    * SAID ON SATURDAY FDA (FOOD&DRUG ADMINISTRATION) DID NOT
GRANT
PERMIT FOR LAUNCHING MED RECORDER ON THE US MARKET
    * FDA JUSTIFIED THE DECISION SAYING THERE IS INSUFFICIENT
EVIDENCE
FOR REFERENCE OF MED RECORDER WITH THE DEVICE THAT IS ALREADY
AUTHORIZED AND PRESENT IN THE US MARKET AND INDICATED IN THE
APPLICATION FORM
    * THE MANAGEMENT OF THE COMPANY PLANS TO CONTINUE EFFORTS
LEADING
TO OBTAINING THE CERTIFICATE FOR MED RECORDER

    
 Source text for Eikon:  urn:newsml:reuters.com:*:nEM4Sn1kXa
    
 Further company coverage:  ISTP.WA  
   


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