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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 91 Results
productcode NIK PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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PMA
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Contak CD,Easytrak, Livian, Cognis and Acuity Spir... Boston Scientific Corp. P010012 S482 04/25/2018
Acuity Spiral Lead Family, Acuity X4 Lead Family Boston Scientific Corp. P010012 S483 05/16/2018
ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, A... Boston Scientific Corp. P010012 S484 07/27/2018
Cardiac Resynchronization Therapy Defibrillator (C... Boston Scientific Corp. P010012 S485 06/01/2018
MANAGE HF Study Boston Scientific Corp. P010012 S486 08/21/2018
Longitudinal Surveillance Registry of the ACUITY S... Boston Scientific Corp. P010012 S487 08/20/2018
Easytrak 2, Easytrack 3, Acuity Sprial, Acuity X4 Boston Scientific Corp. P010012 S488 07/26/2018
Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Ino... Boston Scientific Corp. P010012 S489 09/04/2018
CRT-Ds Autogen, Inogen, Dynagen, Origen, Resonate,... Boston Scientific Corp. P010012 S490 10/10/2018
ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILA... Boston Scientific Corp. P010012 S491 11/16/2018
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