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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode OAD PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
 
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SAFIRE BLU AND THERAPY COOL BI-DIRECTIONAL ABLATIO... IRVINE BIOMEDICAL, INC. P060019 S023 11/29/2012
SAFIRE BLU DUO ABLATION CATHETERS Abbott Medical P110016 S005 11/29/2012
CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER BIOSENSE WEBSTER, INC. P010068 S030 10/24/2012
UNIDIRECTIONAL THERMOCOOL SF NAV CATHETER BIOSENSE WEBSTER, INC. P030031 S045 10/02/2012
BLAZER PRIME XP TEMPERATURE ABLATION CATHETER BOSTON SCIENTIFIC P020025 S035 09/21/2012
THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BL... Abbott Medical P110016 S001 09/13/2012
THERAPY COOL PATH ABLATION CATHETER IRVINE BIOMEDICAL, INC. P060019 S022 09/07/2012
THERAPY COOL PATH DUO ABLATION CATHETER Abbott Medical P110016 S004 09/07/2012
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM IRVINE BIOMEDICAL,INC.(IBI) P040042 S024 08/22/2012
THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 IRVINE BIOMEDICAL, INC. P060019 S020 08/22/2012
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