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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 125 Results
productcode LWS PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S766 12/18/2020
Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Ne... BIOTRONIK, INC. P980023 S104 12/18/2020
Protecta ICD, Protecta VR ICD, and Protecta XT ICD MEDTRONIC CARDIAC RHYTHM DISEA P980016 S759 12/17/2020
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S763 12/16/2020
ACE Header, End Cap, Epicardial Patch Lead and Ups... MEDTRONIC CARDIAC RHYTHM DISEA P900061 S162 12/15/2020
Current+, Fortify, Fortify Assura, Fortify Assura ... Abbott Medical P910023 S434 12/15/2020
Durata, Durata (MR Conditional), Optisure, Optisur... Abbott Medical P950022 S137 12/15/2020
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD,... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S762 12/15/2020
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S765 12/15/2020
Transvene CS/SVS Lead MEDTRONIC Inc. P980050 S130 12/15/2020
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