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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 39 Results
productcode LPB PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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7F Freezor Cardiac Cryoablation Catheter, 7F Freez... Medtronic CryoCath LP P020045 S094 03/17/2021
7F Freezor Cardiac CryoablationCatheter and CCT.2 ... Medtronic CryoCath LP P020045 S096 06/01/2021
Ampere™ Generator St. Jude Medical P960016 S088 10/14/2021
Ampere™ Generator IRVINE BIOMEDICAL, INC. P040014 S045 10/14/2021
Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S052 09/22/2021
Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S048 04/28/2021
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S083 09/22/2021
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S078 04/28/2021
CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS F... Biosense Webster, Inc P950005 S080 09/22/2021
Celsius FLTR (Flutter) Catheter, Celsius Electroph... Biosense Webster, Inc P950005 S081 07/09/2021
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