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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 10 Results
productcode NGV PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Device
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PMA
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Amplatzer Amulet LAA Occluder Abbott Medical P200049 S002 12/09/2021
Amplatzer Amulet Left Atrial Appendage Occluder Abbott Medical P200049 S003 11/16/2021
Amplatzer Amulet Left Atrial Appendage Occluder Abbott Medical P200049 S001 09/22/2021
WATCHMAN Left Atrial Appendage Closure (LAAC) Devi... Boston Scientific Corp. P130013 S046 09/09/2021
WATCHMAN Left Atrial Appendage Closure (LAAC) Devi... Boston Scientific Corp. P130013 S045 08/25/2021
Amplatzer™ Amulet™ Left Atrial Appendage Occluder Abbott Medical P200049 08/14/2021
WATCHMAN FLX Left Atrial Appendage Closure Device ... Boston Scientific Corp. P130013 S042 05/21/2021
WATCHMAN FLX Left Atrial Appendage Closure Device ... Boston Scientific Corp. P130013 S044 05/17/2021
BSC WATCHMAN Left Atrial Appendage Closure (LAAC) ... Boston Scientific Corp. P130013 S038 03/24/2021
WATCHMAN and WATCHMAN FLX Left Atrial Appendage Cl... Boston Scientific Corp. P130013 S041 02/10/2021
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