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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 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
Number
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Decision
Date
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Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S389 09/15/2021
QuickFlex µ and Quartet Abbott Medical P030054 S390 03/18/2021
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S392 06/28/2021
Promote+, Unify, Unify Quadra, Unify Assura, Quadr... Abbott Medical P030054 S393 07/07/2021
Quadra Assura MP, Quadra Assura, Unify Assura Abbott Medical P030054 S394 09/15/2021
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Abbott Medical P030054 S395 09/01/2021
Resonate, Momentum, Vigilant, Autogen, Dynagen, In... Boston Scientific Corp. P010012 S528 10/07/2021
Contak CD, Easytrak, Livian, Cognis and Acuity Spi... Boston Scientific Corp. P010012 S529 02/02/2021
EASYTRAK® 2 1S-1 Coronary Venous Steroid-Eluting B... Boston Scientific Corp. P010012 S531 01/13/2021
ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 ... Boston Scientific Corp. P010012 S532 02/24/2021
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