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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 268 Results
Applicant: St. Jude Medical Product Code: LWS Decision Date to 11/17/2019
 
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Device
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PMA
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Sort by PMA Number [0-9]
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Decision
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durata and optisure hv active steroid eluting cardiac leads St. Jude Medical, Inc. P950022 S128 10/24/2019
ellipse hybrid St. Jude Medical P910023 S420 10/18/2019
ellipse, fortify, fortify assura and quadra assura mp icd St. Jude Medical P910023 S419 10/15/2019
ellipse, fortify, fortify assura, and quadra assura mp icd d... St. Jude Medical P910023 S418 09/04/2019
fortify and fortify assura icd devices St. Jude Medical P910023 S417 08/19/2019
torque wrench/torque driver St. Jude Medical P910023 S416 05/30/2019
current, current accel, current+, ellipse, fortify, fortify ... St. Jude Medical P910023 S414 03/13/2019
durata, optisure high voltage passive, high voltage active St. Jude Medical, Inc. P950022 S126 12/17/2018
tendril sts 2088tc lead St. Jude Medical P910023 S410 12/13/2018
cortify, fortify assura, and ellipse St. Jude Medical P910023 S415 12/11/2018
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