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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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Various models of dual chamber ICDS in the Ilivia,... BIOTRONIK, INC. P050023 S103 05/03/2017
SMARTVIEW hotspot; Orchestra Plus Link MicroPort CRM USA Inc. P980049 S126 07/27/2017
PSW 1704.U BIOTRONIK, INC. P050023 S113 12/12/2017
PSW 1704.U BIOTRONIK, INC. P000009 S075 12/12/2017
PSW 1703.U BIOTRONIK, INC. P000009 S074 08/31/2017
PSW 1703.U BIOTRONIK, INC. P050023 S112 08/31/2017
PSW 1601.U Pacemaker/ICD/CRT non implanted compone... BIOTRONIK, INC. P050023 S104 03/24/2017
PSW 1601.U Pacemaker/ICD/CRT non implanted compone... BIOTRONIK, INC. P000009 S069 03/24/2017
ProMRI ICD/CRT-D System BIOTRONIK, INC. P050023 S110 07/21/2017
Platinium VR and Platinium DR ICD's (Implantable C... MicroPort CRM USA Inc. P980049 S124 03/20/2017
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