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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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31 to 39 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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Smartablate System Interface Cables BIOSENSE WEBSTER, INC. P990071 S050 07/09/2021
Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S052 09/22/2021
Celsius, Celsius Flutter, EZ Steer Biosense Webster, Inc P950005 S076 02/02/2021
Celsius, Celsius RMT, EZ Steer Bi-directional non ... Biosense Webster, Inc P950005 S077 04/07/2021
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S078 04/28/2021
CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOC... Biosense Webster, Inc P950005 S079 04/27/2021
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
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S083 09/22/2021
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