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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 18 Results
productcode MRM PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
 
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IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & ... BIOTRONIK, INC. P050023 S087 12/21/2015
BIOTRONIK ICD FAMILIES BIOTRONIK, INC. P050023 S090 12/18/2015
SMARTVIEW REMOTE MONITORING SYSTEM MicroPort CRM USA Inc. P980049 S105 09/16/2015
PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750... MicroPort CRM USA Inc. P980049 S110 07/31/2015
PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL 101) & ... MicroPort CRM USA Inc. P980049 S111 07/31/2015
PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 97... MicroPort CRM USA Inc. P980049 S112 07/31/2015
COROX OTW 75-UP STEROID,COROX OTW 85 UP STEROID BIOTRONIK, INC. P050023 S084 07/17/2015
IPERIA 7 VR-T (DF-1),IPERIA 7 VR-T (DF-4),ITREVIA ... BIOTRONIK, INC. P050023 S092 06/22/2015
INVENTRA CRT-D BIOTRONIK, INC. P050023 S085 06/19/2015
ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA... BIOTRONIK, INC. P050023 S091 06/12/2015
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