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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 24 Results
productcode OAD PMA Number p Decision Date From 1/1/2011 Decision Date To 1/1/2012
 
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THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-... BIOSENSE WEBSTER, INC. P030031 S025 12/21/2011
THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315... BIOSENSE WEBSTER, INC. P030031 S034 12/21/2011
THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-X... BIOSENSE WEBSTER, INC. P990071 S009 12/21/2011
THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315... BIOSENSE WEBSTER, INC. P990071 S013 12/21/2011
BLAZER II XP CARDIAC ABLATION CATHETER & CABLE BOSTON SCIENTIFIC P020025 S032 12/05/2011
MAESTRO 3000 CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S031 11/17/2011
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM IRVINE BIOMEDICAL,INC.(IBI) P040042 S023 11/10/2011
THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 IRVINE BIOMEDICAL, INC. P060019 S019 11/10/2011
CELSIUS & NAVISTAR DS CATHETER/NAVISTAR RMT/EZ STE... BIOSENSE WEBSTER, INC. P010068 S025 10/07/2011
MAESTRO 3000 CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S030 08/18/2011
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