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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 67 Results
productcode NIK PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Device
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PMA
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COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S539 09/17/2021
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S389 09/15/2021
Quadra Assura MP, Quadra Assura, Unify Assura Abbott Medical P030054 S394 09/15/2021
Amplia MRI CRTD, Amplia MRI Quad, Brava CRT-D, Bra... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S756 09/10/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S755 09/01/2021
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Abbott Medical P030054 S395 09/01/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S754 08/17/2021
CareLink SmartSync Cobalt, Crome Application MEDTRONIC CARDIAC RHYTHM DISEA P010031 S747 08/16/2021
Smart Monitor, Smart Spot, SmartView Monitor, Smar... MicroPort CRM USA Inc. P060027 S105 08/13/2021
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S753 08/12/2021
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