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BRIEF-ProstaLund Files Application To FDA For Schelin Catheter

BRIEF-ProstaLund Files Application To FDA For Schelin Catheter

Reuters · 07/28/2022 01:10
BRIEF-ProstaLund Files Application To FDA For Schelin Catheter

- 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:

Further company coverage: PLUND.ST


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