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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 UNI-DIRECTIONAL CATHETER (D-1315... BIOSENSE WEBSTER, INC. P990071 S013 12/21/2011
THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-X... BIOSENSE WEBSTER, INC. P990071 S009 12/21/2011
THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 IRVINE BIOMEDICAL, INC. P060019 S019 11/10/2011
THERAPY COOL PATH ABLATION CATHETER IRVINE BIOMEDICAL, INC. P060019 S017 02/17/2011
THERAPY COOL PATH ABLATION CATHETER IRVINE BIOMEDICAL, INC. P060019 S015 01/11/2011
SAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY C... IRVINE BIOMEDICAL, INC. P060019 S009 02/23/2011
THERAPY DUAL 8 CARDIAC ABLATION SYSTEM IRVINE BIOMEDICAL,INC.(IBI) P040042 S023 11/10/2011
THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX AB... IRVINE BIOMEDICAL,INC.(IBI) P040042 S022 06/06/2011
THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX AB... IRVINE BIOMEDICAL,INC.(IBI) P040042 S021 02/17/2011
THERAPY DUAL 8 ABLATION CATHETER IRVINE BIOMEDICAL,INC.(IBI) P040042 S020 01/11/2011
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