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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 12 Results
productcode NKM PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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PMA
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PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 S005 12/20/2022
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR... Abbott Medical P100009 S050 12/15/2022
PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 S003 12/07/2022
PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 S004 12/07/2022
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR... Abbott Medical P100009 S049 11/20/2022
PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 S002 11/20/2022
PASCAL Precision – Implant System (PASCAL Implant,... Edwards LifeSciences LLC P220003 S001 10/19/2022
MitraClip™ NTR Clip Delivery System, MitraClip™ XT... Abbott Medical P100009 S048 10/17/2022
PASCAL Precision Transcatheter Valve Repair System Edwards LifeSciences LLC P220003 09/14/2022
MitraClip™ Clip Delivery System Abbott Medical P100009 S047 09/09/2022
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