Brief: ProstaLund Files Application To FDA For Schelin Catheter

ProstaLund AB

28/07/2022 06:10

July 28 (Reuters) - ProstaLund AB  PLUND.ST :
    * SAID ON WEDNESDAY HAS FILED ITS 510(K) APPLICATION TO THE
FDA
FOR THE SCHELIN CATHETER
    * HAS SUBMITTED ITS APPLICATION FOR 510(K) APPROVAL TO U.S.
FOOD
AND DRUG ADMINISTRATION (FDA) FOR SCHELIN CATHETERTM
    * SUBMISSION OF OUR APPLICATION TO FDA TODAY IS A VERY
IMPORTANT
MILESTONE FOR PROSTALUND AND A POSITIVE RESULT OF INTENSIVE WORK
CARRIED OUT BY OUR REGULATORY DEPARTMENT
    * OBJECTIVE HAS BEEN TO PROVIDE FDA WITH AN APPLICATION THAT
MEETS
THEIR REQUIREMENTS FOR INFORMATION AND DATA IN BEST POSSIBLE WAY
    * THIS APPLICATION TAKES US ONE STEP CLOSER TO INTRODUCE
SCHELIN
CATHETER IN IMPORTANT U.S. MARKET

Source text for Eikon:  ID:nMFN3drnjc 
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