Brief: Surmodics Provides Update Related To FDA Premarket Approval Application

SurModics

19/01/2023 12:48

Jan 19 (Reuters) - Surmodics Inc  SRDX.O :
    * SURMODICS PROVIDES REGULATORY UPDATE RELATED TO ITS FDA
PREMARKET APPROVAL APPLICATION FOR THE SURVEIL™ DRUG-COATED
BALLOON
    * SURMODICS INC - FDA INDICATED THAT APPLICATION IS NOT
CURRENTLY
APPROVABLE, WHILE PROVIDING SPECIFIC GUIDANCE AS TO A PATH
FORWARD
    * SURMODICS INC - FDA LETTER DID NOT QUESTION HUMAN CLINICAL
DATA
SUBMITTED NOR REQUEST ANY FURTHER HUMAN CLINICAL DATA

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