Brief: Seastar Medical Provides Regulatory Update Related To Its Hde Application For Pediatric Selective Cytopheretic Device

SeaStar Medical Holding

09/05/2023 22:59

SeaStar Medical Holding Corp  ICU.O :
    * SEASTAR MEDICAL PROVIDES REGULATORY UPDATE RELATED TO ITS
HDE
APPLICATION FOR PEDIATRIC SELECTIVE CYTOPHERETIC DEVICE
    * SEASTAR MEDICAL HOLDING CORP - RECEIVED A LETTER FROM
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH OF U.S. FOOD AND DRUG
ADMINISTRATION
    * SEASTAR MEDICAL: IN LETTER, FDA INDICATED CO'S APPLICATION
FOR
ITS PEDIATRIC SELECTIVE CYTOPHERETIC DEVICE IS NOT APPROVABLE IN
ITS CURRENT FORM
    * SEASTAR MEDICAL HOLDING CORP - AGENCY'S DECISION LETTER ON
PEDIATRIC HDE DOES NOT AFFECT COMPANY'S PIVOTAL CLINICAL TRIAL
WITH SCD IN ADULTS WITH AKI

Source text for Eikon:  ID:nGNXjCTDj 
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