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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 13 Results
productcode OUT PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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Pipeline™ Flex Embolization Device, Pipeline™ Flex... Micro Therapeutics, Inc. d/b/a P100018 S036 12/27/2021
Surpass Evolve Flow Diverter System Stryker Neurovascular P170024 S011 11/30/2021
Flow Re-Direction Endoluminal Device (FRED®) Syste... MicroVention, Inc. P180027 S002 09/16/2021
Pipeline Flex Embolization Device and Pipeline Fle... Micro Therapeutics, Inc. d/b/a P100018 S033 07/27/2021
Pipeline Flex Embolization Device with Shield Tech... Micro Therapeutics, Inc. d/b/a P100018 S032 07/19/2021
Flow Re-Direction Endoluminal Device (FRED®) Syste... MicroVention, Inc. P180027 S003 07/16/2021
Surpass Evolve Flow Diverter System Stryker Neurovascular P170024 S009 07/12/2021
Surpass Streamline Flow Diverter System, Surpass E... Stryker Neurovascular P170024 S008 06/09/2021
Flow Re-Direction Endoluminal Device (FRED) System MicroVention, Inc. P180027 S004 05/25/2021
Pipeline Flex Embolization Device Micro Therapeutics, Inc. d/b/a P100018 S029 04/29/2021
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