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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 18 of 18 Results
productcode MRM PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
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LUMAX DR-T, LUMAX VR-T AND LUMAX CRT-D BIOTRONIK, INC. P050023 S086 05/27/2015
CARDIOMESSENGER BIOTRONIK, INC. P050023 S088 05/14/2015
IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-... BIOTRONIK, INC. P050023 S083 04/09/2015
IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS L... BIOTRONIK, INC. P050023 S081 03/19/2015
PARADYM (VR/DR) 8750, PARADYM RF (VR/DR) 9750(ZL10... MicroPort CRM USA Inc. P980049 S108 03/19/2015
PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 97... MicroPort CRM USA Inc. P980049 S106 03/17/2015
PARADYM (VR/DR) 8750, PARADYM RF VR 9750, PARADYM ... MicroPort CRM USA Inc. P980049 S107 03/13/2015
IPERIA FAMILY ICD/CRT-D: IPERIA ITREVIA AND INVENT... BIOTRONIK, INC. P050023 S079 02/10/2015
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