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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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PMA
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PSW 1704.U BIOTRONIK, INC. P000009 S075 12/12/2017
PSW 1704.U BIOTRONIK, INC. P050023 S113 12/12/2017
PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711... MicroPort CRM USA Inc. P980049 S123 10/26/2017
PSW 1703.U BIOTRONIK, INC. P000009 S074 08/31/2017
PSW 1703.U BIOTRONIK, INC. P050023 S112 08/31/2017
Blind plug BS IS4 BIOTRONIK, INC. P050023 S111 08/16/2017
Llivia, Inlexa, Intica 7/5, VR-T/ DR-T DF4 BIOTRONIK, INC. P050023 S109 08/02/2017
SMARTVIEW hotspot; Orchestra Plus Link MicroPort CRM USA Inc. P980049 S126 07/27/2017
Paradym and Paradym RF, Update to Platinium Embedd... MicroPort CRM USA Inc. P980049 S125 07/26/2017
ProMRI ICD/CRT-D System BIOTRONIK, INC. P050023 S110 07/21/2017
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