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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 12 Results
productcode OAD PMA Number p Decision Date From 1/1/2010 Decision Date To 1/1/2011
 
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PMA
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SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL AB... IRVINE BIOMEDICAL, INC. P060019 S016 12/23/2010
THERAPY COOL PATH ABLATION CATHETER IRVINE BIOMEDICAL, INC. P060019 S013 12/03/2010
COOL POINT TUBING SET IRVINE BIOMEDICAL, INC. P060019 S014 10/29/2010
NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKST... BIOSENSE WEBSTER, INC. P010068 S020 10/01/2010
BLAZER II XP/BLAZER PRIME XP ABLATION CATHETERS BOSTON SCIENTIFIC P020025 S024 08/26/2010
BLAZER PRIME XP CATHETER BOSTON SCIENTIFIC P020025 S023 06/30/2010
THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX AB... IRVINE BIOMEDICAL,INC.(IBI) P040042 S018 03/23/2010
THERAPY COOL PATH ABLATION CATHETER IRVINE BIOMEDICAL, INC. P060019 S011 03/23/2010
NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKST... BIOSENSE WEBSTER, INC. P010068 S019 03/04/2010
EPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND... BOSTON SCIENTIFIC P020025 S022 02/22/2010
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