Brief: Spectral Says In Dialogue With US FDA For Collection Of More Information Regarding Safety And Efficacy For PMX Cartridge

Spectral Medical

30/05/2018 13:51

May 30 (Reuters) - Spectral Medical Inc  EDT.TO :
    * SPECTRAL PROVIDES CORPORATE UPDATE
    * SPECTRAL MEDICAL - UNDERGOING INTERACTIVE DIALOGUE WITH US
FDA
AIMED AT COLLECTION OF MORE INFORMATION REGARDING SAFETY AND
EFFICACY FOR PMX CARTRIDGE
    * SPECTRAL MEDICAL - RECEIVED ACKNOWLEDGEMENT  IT HAS
SUCCESSFULLY
PASSED MEDICAL DEVICES SINGLE AUDIT PROGRAM FOR MANUFACTURING
FACILITY IN TORONTO
    * SPECTRAL MEDICAL INC -  GOAL OF DIALOGUE WITH U.S. FDA IS
TO ADD
MORE INFORMATION TO DATA ALREADY OBTAINED IN EUPHRATES TRIAL

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