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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 27 Results
productcode MLV PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Gore Cardioform ASD Occluder W.L. GORE & ASSOCIATES,INC P050006 S081 11/19/2019
GORE CARDIOFORM ASD Occluder and Septal Occluder W.L. GORE & ASSOCIATES,INC P050006 S080 10/31/2019
Amplatzer Septal Occluder and Amplatzer Multi-Fene... Abbott Medical P000039 S068 10/25/2019
Amplatzer Muscular VSD Occluder Abbott Medical P040040 S038 10/25/2019
Amplatzer PFO Occluder Abbott Medical P120021 S013 10/25/2019
GORE CARDIOFORM Septal Occulder W.L. GORE & ASSOCIATES,INC P050006 S075 10/02/2019
GORE CARDIOFORM Septal Occluder (GSO) W.L. GORE & ASSOCIATES,INC P050006 S077 09/17/2019
THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMP... Abbott Medical P000039 S067 08/22/2019
AMPLATZER MUSCULAR VSD OCCLUDER Abbott Medical P040040 S037 08/22/2019
AMPLATZER PFO OCCLUDER Abbott Medical P120021 S012 08/22/2019
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