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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 22 Results
productcode NKE PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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invive, intua, visionist, valitude GUIDANT CORP. P030005 S212 11/30/2021
sentus promri otw qp s, sentus promri otw qp s-xx/... BIOTRONIK, INC. P070008 S132 10/29/2021
valitude™ crt-p; valitude x4 crt-p GUIDANT CORP. P030005 S214 10/21/2021
valitude crt-p, visionist crt-p GUIDANT CORP. P030005 S213 09/24/2021
invive, intua, visionist, valitude GUIDANT CORP. P030005 S211 09/17/2021
anthem, allure/rf, allure quadra/rf family of crt-... Abbott Medical P030035 S184 09/15/2021
valitude, valitude x4, visionist, visionist x4 GUIDANT CORP. P030005 S210 09/03/2021
sentus qp leads BIOTRONIK, INC. P070008 S129 09/03/2021
etrinsa 8 hf-t, epyra 8 hf-t, eluna 8 hf-t BIOTRONIK, INC. P070008 S128 08/19/2021
evia hf-t, etrinsa 8 hf-t, epyra 8 hf-t, eluna 8 h... BIOTRONIK, INC. P070008 S127 07/21/2021
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