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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 14 Results
productcode MLV PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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AmplatzerTM PFO Occluder and AmplatzerTM TalismanT... Abbott Medical P120021 S023 12/22/2021
GORE CARDIOFORM Septal Occluder W.L. GORE & ASSOCIATES,INC P050006 S093 12/21/2021
GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM... W.L. GORE & ASSOCIATES,INC P050006 S096 11/29/2021
GORE® CARDIOFORM ASD Occluder W.L. GORE & ASSOCIATES,INC P050006 S095 11/16/2021
Amplatzer™ Talisman™ PFO Occluder Abbott Medical P120021 S020 09/27/2021
Amplatzer Septal Occluder Abbott Medical P000039 S075 09/22/2021
GORE CARDIOFORM Septal Occluder W.L. GORE & ASSOCIATES,INC P050006 S094 08/13/2021
GORE CARDIOFORM Septal Occluder and GORE CARDIOFOR... W.L. GORE & ASSOCIATES,INC P050006 S091 08/02/2021
Amplatzer Septal Occluder, Amplatzer Multi-Fenestr... Abbott Medical P000039 S074 07/27/2021
Amplatzer Muscular VSD Occluder Abbott Medical P040040 S044 07/27/2021
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