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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 25 Results
productcode OAD PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
 
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CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR... Biosense Webster, Inc P950005 S047 01/22/2014
COOL POINT(TM) TUBING SET IRVINE BIOMEDICAL, INC. P060019 S025 05/19/2014
THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8... IRVINE BIOMEDICAL,INC.(IBI) P040042 S027 04/28/2014
THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8... IRVINE BIOMEDICAL,INC.(IBI) P040042 S026 03/21/2014
BLAZER II XP TEMPERATURE ABLATION CATHETER BOSTON SCIENTIFIC P020025 S065 12/17/2014
BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION... BOSTON SCIENTIFIC P020025 S064 10/21/2014
INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER BOSTON SCIENTIFIC P020025 S063 07/18/2014
INTELLATIP MIFI FILTER MODULE, INTELLATIP MIFI REF... BOSTON SCIENTIFIC P020025 S062 07/14/2014
BLAZER II XP CARDIAC ABLATION CATHETER BOSTON SCIENTIFIC P020025 S061 12/08/2014
MAESTRO 4000 CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S060 12/19/2014
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