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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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Applicant
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PMA
Number
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Decision
Date
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Smart Monitor, Smart Spot, SmartView Monitor, Smar... MicroPort CRM USA Inc. P060027 S105 08/13/2021
Resonate, Momentum, Vigilant, Autogen, Dynagen, In... Boston Scientific Corp. P010012 S528 10/07/2021
Resonate family of CRT-D's Boston Scientific Corp. P010012 S540 10/07/2021
QuickFlex µ and Quartet Abbott Medical P030054 S390 03/18/2021
Quadra Assura MP, Quadra Assura, Unify Assura Abbott Medical P030054 S394 09/15/2021
Promote/+/RF/Q, Promote Accel, Promote Quadra, Uni... Abbott Medical P030054 S389 09/15/2021
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
ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, MOMENTUM™ CRT-D, ... Boston Scientific Corp. P010012 S549 12/21/2021
ORIGEN CRT-D; ORIGEN X4 CRT-D; INOGEN CRT-D; INOGE... Boston Scientific Corp. P010012 S547 10/21/2021
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