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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode NKM PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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MitraClip™ NTR/XTR Clip Delivery System, MitraClip... Abbott Medical P100009 S062 12/01/2023
MitraClip™ G4 Clip Delivery System Abbott Medical P100009 S055 11/20/2023
PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 S014 11/13/2023
MitraClip™ G4 Clip Delivery System Abbott Medical P100009 S060 10/27/2023
PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 S013 10/18/2023
MitraClip™ NTR/XTR Clip Delivery System, MitraClip... Abbott Medical P100009 S059 10/17/2023
MitraClip G4 Delivery System Abbott Medical P100009 S058 10/12/2023
MitraClip™ G4 Clip Delivery System Abbott Medical P100009 S057 08/30/2023
MitraClip™ Clip Delivery System Abbott Medical P100009 S052 08/23/2023
PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 S007 07/06/2023
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