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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Device
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PMA
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promote/+/rf/q, promote accel, promote quadra, uni... Abbott Medical P030054 S373 12/23/2019
quadripolar pacing Abbott Medical P030054 S372 12/20/2019
brava crt-d, brava quad crt-d, viva quad crt-d, vi... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S683 12/16/2019
amplia mri, amplia mri quad, brava, brava quad, cl... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S684 12/10/2019
acuity x4 electrode 2, 3, and (e24) Boston Scientific Corp. P010012 S512 12/06/2019
origen crt-d, origen x4 crt-d, momentum, momentum ... Boston Scientific Corp. P010012 S513 12/04/2019
platinium 4lv crt-d MicroPort CRM USA Inc. P060027 S100 12/04/2019
amplia mri crt-d, amplia/claria/compia mri quad cr... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S685 12/03/2019
contak cd,easytrak, livian, cognis and acuity spir... Boston Scientific Corp. P010012 S511 11/15/2019
amplia mri crt-d, amplia mri quad crt-d, brava cr... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S682 11/01/2019
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