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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 24 Results
productcode MRM PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711... MicroPort CRM USA Inc. P980049 S123 10/26/2017
Platinium VR and Platinium DR ICD's (Implantable C... MicroPort CRM USA Inc. P980049 S124 03/20/2017
Paradym and Paradym RF, Update to Platinium Embedd... MicroPort CRM USA Inc. P980049 S125 07/26/2017
SMARTVIEW hotspot; Orchestra Plus Link MicroPort CRM USA Inc. P980049 S126 07/27/2017
PHYLAX AV ICD SYSTEM BIOTRONIK, INC. P000009 S067 02/08/2017
Pacemaker/ICD/CRT non implanted components; PSW 16... BIOTRONIK, INC. P000009 S068 05/03/2017
PSW 1601.U Pacemaker/ICD/CRT non implanted compone... BIOTRONIK, INC. P000009 S069 03/24/2017
PACEMAKER ICD CRT NON IMPLANTED COMPONENTS BIOTRONIK, INC. P000009 S070 05/04/2017
Pacemaker ICD CRT Non Implanted components. BIOTRONIK, INC. P000009 S071 05/06/2017
Lumos DR-T/VR-T BIOTRONIK, INC. P000009 S072 05/06/2017
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