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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 150 Results
PMA Number P070008 Decision Date To 04/28/2024
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PSW 2100.U and NEO 2100.U BIOTRONIK, INC. P070008 S122 04/30/2021
Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 H... BIOTRONIK, INC. P070008 S123 04/14/2021
Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW... BIOTRONIK, INC. P070008 S116 03/08/2021
Edora 8 CRT-P, Evity 8 CRT-P, and Enitra 8 CRT-P a... BIOTRONIK, INC. P070008 S118 12/18/2020
STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW... BIOTRONIK, INC. P070008 S121 12/18/2020
Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T BIOTRONIK, INC. P070008 S120 12/01/2020
Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Ev... BIOTRONIK, INC. P070008 S119 11/17/2020
Home Monitoring System Version 3.48 BIOTRONIK, INC. P070008 S117 11/05/2020
PSW 1904.U BIOTRONIK, INC. P070008 S115 05/29/2020
Quadripolar CRT-D Systems BIOTRONIK, INC. P070008 S114 05/22/2020
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