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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 30 Results
productcode OAD PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
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UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX ... BIOSENSE WEBSTER, INC. P010068 S031 06/06/2013
7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELE... BIOSENSE WEBSTER, INC. P010068 S034 05/29/2013
CELCIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTA... BIOSENSE WEBSTER, INC. P010068 S033 04/25/2013
BLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII X... BOSTON SCIENTIFIC P020025 S040 04/18/2013
BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABL... Abbott Medical P110016 S006 04/18/2013
CELSIUS DS, NAVISTAR DS,NAVISTAR RMT DS, EZ STEER ... BIOSENSE WEBSTER, INC. P010068 S028 04/12/2013
BLAZER PRIME XP CARDIAC ABLATION CATHETERS BOSTON SCIENTIFIC P020025 S039 04/01/2013
NAVISTAR® AND CELSIUS® DS DIAGNOSTIC/ABLATION DEFL... BIOSENSE WEBSTER, INC. P010068 S027 03/07/2013
EPT-1000 XP RF ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S038 02/22/2013
BLAZER PRIME XP AND BLAZER II XP CARDIAC ABLATION ... BOSTON SCIENTIFIC P020025 S037 01/22/2013
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